510(k) · Cleared

Cleared

JJG Evolution Orthodontic Implant System

K072917510(k) TraditionalCleared Jan 14, 200894-day reviewClass II21 CFR 872.3640

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Odontit S.A. · DZE Implant, Endosseous, Root-Form

Cleared on Jan 14, 2008 as substantially equivalent to K980620 (Dentatus USA, Ltd., 1998) and 22 other predicates after a 94-day review. Its family tree reaches back 9 generations to 1990.

Decided: Jan 14, 2008
Review: 94 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 23

Its longest line of descent runs back 9 generations to K894595 (1990). 135 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.

By dateBy generation

Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
5 generations between
3 generations backK052490 Endosseous Dental Implant SystemNorthern Implants, LLC · 2005
2 generations backK061169 Endosseous Dental ImplantNorthern Implants, LLC · 2006
1 generation backK070905 Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007 · Recalled
This deviceK072917 JJG Evolution Orthodontic Implant SystemOdontit S.A. · 2008

Show all 9 generations

Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
7 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
6 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
5 generations backK024004 Xive Transgingival Dental Implant SystemFriadent GmbH · 2003
4 generations backK033171 Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC · 2004
3 generations backK052490 Endosseous Dental Implant SystemNorthern Implants, LLC · 2005
2 generations backK061169 Endosseous Dental ImplantNorthern Implants, LLC · 2006
1 generation backK070905 Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007 · Recalled
This deviceK072917 JJG Evolution Orthodontic Implant SystemOdontit S.A. · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−9	K894595	Bonefit R Screw Implants	Institut Straumann AG	1990	—
−8	K984104	Iti Dental Implant System	Straumann USA	1999	1
−7	K992937	Dental Implant	Nobel Biocare Uas, Inc.	2000	1
−6	K013067	Frialoc Dental Implant System	Friadent GmbH	2002	—
−5	K024004	Xive Transgingival Dental Implant System	Friadent GmbH	2003	—
−4	K033171	Nsi Hexed and Non-Hexed Implant System and Immediate Loading	Northern Implants, LLC	2004	—
−3	K052490	Endosseous Dental Implant System	Northern Implants, LLC	2005	—
−2	K061169	Endosseous Dental Implant	Northern Implants, LLC	2006	—
−1	K070905	Endosseous Dental Implant System	Southern Implants, Inc.	2007	1
0 (this device)	K072917	JJG Evolution Orthodontic Implant System	Odontit S.A.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1978	1	0
1982	1	0
1984	2	0
1985	1	0
1986	1	0
1988	1	0
1989	4	0
1990	4	0
1992	4	0
1993	14	0
1994	6	0
1995	8	0
1996	10	0
1997	7	0
1998	8	0
1999	7	0
2000	4	0
2001	10	0
2002	8	0
2003	6	0
2004	5	0
2005	2	0
2006	9	0
2007	3	0

FIG. 1 — Lineage of K072917, 1990–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DZE device

#1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (23)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K980620	Dentatus Mti Modular Transitional Implants and Prosthetic System Summary page 1 …equivalent to several small implant systems currently on the market. Some of these are: Dentatus MTI Modular Transitional Implants cleared in K980620, MTI-MP Transitional Implants, cleared by Dentatus USA in K961704, Sendax MDI cleared by Sendax MDIC Management in…	Dentatus USA, Ltd.	1998	—
*	K961704	Mti-MP Transitional Implants and Modular Prosthetic System Summary page 1 …t. Some of these are: Dentatus MTI Modular Transitional Implants cleared in K980620, MTI-MP Transitional Implants, cleared by Dentatus USA in K961704, Sendax MDI cleared by Sendax MDIC Management in K972351, the Bicortical Screw, cleared by Oraltronics in K983120,…	Dentatus USA, Ltd.	1996	—
*	K972351	Sendax Mdi (Mini Dental Implant) Summary page 1 …cleared in K980620, MTI-MP Transitional Implants, cleared by Dentatus USA in K961704, Sendax MDI cleared by Sendax MDIC Management in K972351, the Bicortical Screw, cleared by Oraltronics in K983120, and 10 3i…	Sendax Mdic Management, Inc.	1997	—
*	K983120	Bicortical Screw Summary page 1 …cleared by Dentatus USA in K961704, Sendax MDI cleared by Sendax MDIC Management in K972351, the Bicortical Screw, cleared by Oraltronics in K983120, and 10 3i Stnd Threaded/Self Tapping, Threaded/31 Miniplant Implan…	Oraltronics Marketing-Und Vertriebs GmbH	1999	—
*	K960417	3I STND Threaded/Self Tapping Threaded/3I Miniplant Implants/3 I Emergence Prof. Temp.… Summary page 2 …10 3i Stnd Threaded/Self Tapping, Threaded/31 Miniplant Implants, cleared by Implant Innovations, Inc., in K960417, JJG Evolution TM Mini-Implant system implants are substantially equivalent to the Dentatus MT] implants in that they are manufa…	Implant Innovations, Inc.	1996	—
*	K063770	Alpha-Bio Orthodontic Fixation Screw System Summary page 3 …ivalence: The JJG EvolutionTM system is substantially equivalent to several small implant systems currently on the market. Some of these are: K063770 by Alpha-Bio Tec, K062733 by Dentaurum, K062367 by the Micerium Group, K062156 by Osstem Implant Co., K060062 by…	Alpha-Bio Tec, Ltd.	2007	—
*	K062733	Tomas Pin SD 6, 8, and 10 MM Summary page 3 …nTM system is substantially equivalent to several small implant systems currently on the market. Some of these are: K063770 by Alpha-Bio Tec, K062733 by Dentaurum, K062367 by the Micerium Group, K062156 by Osstem Implant Co., K060062 by Institut Strau…	Dentaurum	2006	—
*	K062367	Miniscrews Anchoring System, M.a.S. Summary page 3 …ially equivalent to several small implant systems currently on the market. Some of these are: K063770 by Alpha-Bio Tec, K062733 by Dentaurum, K062367 by the Micerium Group, K062156 by Osstem Implant Co., K060062 by Institut Straumann, K050568 by Ortho…	Micerium S.P.A.	2006	—
*	K062156	Super Orthodontic Screw Summary page 3 …ll implant systems currently on the market. Some of these are: K063770 by Alpha-Bio Tec, K062733 by Dentaurum, K062367 by the Micerium Group, K062156 by Osstem Implant Co., K060062 by Institut Straumann, K050568 by Ortholution Co., K042965 by Dentarum,…	Osstem Implant Co., Ltd.	2006	—
*	K060062	Straumann Orthosystem Summary page 3 …the market. Some of these are: K063770 by Alpha-Bio Tec, K062733 by Dentaurum, K062367 by the Micerium Group, K062156 by Osstem Implant Co., K060062 by Institut Straumann, K050568 by Ortholution Co., K042965 by Dentarum,…	Institut Straumann AG	2006	2
*	K050568	Orlus Mini Screw Summary page 3 …K063770 by Alpha-Bio Tec, K062733 by Dentaurum, K062367 by the Micerium Group, K062156 by Osstem Implant Co., K060062 by Institut Straumann, K050568 by Ortholution Co., K042965 by Dentarum, 10 Inc., and K031936 by Ost…	Ortholution Co., Ltd.	2005	—
*	K042965	Tomas Pin Summary page 3 …062733 by Dentaurum, K062367 by the Micerium Group, K062156 by Osstem Implant Co., K060062 by Institut Straumann, K050568 by Ortholution Co., K042965 by Dentarum, 10 Inc., and K031936 by Osteomed. The implant is intend…	Dentaurum, Inc.	2005	—
*	K031936	Osteomed Orthodontic Screw System Summary page 4 …, K060062 by Institut Straumann, K050568 by Ortholution Co., K042965 by Dentarum, 10 Inc., and K031936 by Osteomed. The implant is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate th…	Osteomed LP	2004	—
*	K071235	Zimmer One Piece Implant, 3.0MM Angled, Models ZOP30A10, ZOP30A11 and ZOP30A13 Summary page 7 …market. Some of these are: Repl. p. 11 1. Zimmer One Piece Implant, Zimmer Dental Inc., K071235, 2. Endosseous Dental Implant System, K070905, 3. Mistral -One Stage Screw-Type Dental Implants, M.…	Zimmer Dental, Inc.	2007	1
*	K070905	Endosseous Dental Implant System Summary page 7 …Repl. p. 11 1. Zimmer One Piece Implant, Zimmer Dental Inc., K071235, 2. Endosseous Dental Implant System, K070905, 3. Mistral -One Stage Screw-Type Dental Implants, M.IS. Implants Technologies, Inc., K070022,…	Southern Implants, Inc.	2007	1
*	K070022	Mistral - One Stage Screw-Type Dental Implant, Model MF9 Summary page 7 …2. Endosseous Dental Implant System, K070905, 3. Mistral -One Stage Screw-Type Dental Implants, M.IS. Implants Technologies, Inc., K070022, 4. Zimmer One-Piece Implant, Zimmer Dental Inc., K062281, 5. Fixature Microthread Osseospeed, Astr…	Mis Implants Technologies, Ltd.	2007	—
*	K062281	Zimmer One-Piece Implant, 4.7MM, Straight, Models ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16 Summary page 7 …tral -One Stage Screw-Type Dental Implants, M.IS. Implants Technologies, Inc., K070022, 4. Zimmer One-Piece Implant, Zimmer Dental Inc., K062281, 5. Fixature Microthread Osseospeed, Astra Tech, Inc., K053384. 6. Straumann Dental Implant System,…	Zimmer Dental, Inc.	2006	—
*	K053384	Fixature Microthread Osseospeed, a Component of the Astra Tech Implant System Summary page 7 …echnologies, Inc., K070022, 4. Zimmer One-Piece Implant, Zimmer Dental Inc., K062281, 5. Fixature Microthread Osseospeed, Astra Tech, Inc., K053384. 6. Straumann Dental Implant System, Institut Straumann AG, K033984, 7. Replace O…	Astra Tech, Inc.	2006	—
*	K033984	Straumann Dental Implant System Summary page 7 …5. Fixature Microthread Osseospeed, Astra Tech, Inc., K053384. 6. Straumann Dental Implant System, Institut Straumann AG, K033984, 7. Replace One Piece Implant, Nobel Biocare UAS, Inc., K023952, 8. Odont Hex System, Odontit SA, K…	Institut Straumann AG	2004	—
*	K023952	Replace One Piece Implant, HA, Replace One Piece Implant, Tiunite Summary page 7 …6. Straumann Dental Implant System, Institut Straumann AG, K033984, 7. Replace One Piece Implant, Nobel Biocare UAS, Inc., K023952, 8. Odont Hex System, Odontit SA, K961631, 9. Odontit Osseointegrated Implants System, Odontit SA,…	Nobel Biocare Uas, Inc.	2003	—
*	K961631	Odont Hex System Summary page 7 …t Straumann AG, K033984, 7. Replace One Piece Implant, Nobel Biocare UAS, Inc., K023952, 8. Odont Hex System, Odontit SA, K961631, 9. Odontit Osseointegrated Implants System, Odontit SA, K-91 5375. The J.J.G. EvolutionTM Monoblock Implants Syst…	Odontit S.A.	1997	—
*	K915375	Odontit Osseointegrated Implants System Summary page 7 …nd Drug Administration premarket notification submissions, K071235, K062281, and the Odontit Hex System (K961631) and Odontit Osseointegrated Implants system, cleared in K915375. Like these products, the J.J.G. EvolutionTM Monoblock Implants System devices are manufactured of titanium alloy (ASTM F 136-84…	Odontit Systeme	1992	—
*	K011502	Crystal and Crystal-Care Implants System Summary page 7 …evices, the J.J.G. EvolutionTM Monoblock Implants are post-type, tapered form, with spirals. Like some of them (e.g. K023972, Replace One Piece implant of Nobel BioCare; K011502, K071235, K062261, Zimmer Dental, Inc.,) they are manufactured with the root form treated to roughen itor otherwise hasten osseoi…	Crystal-Seal Dental Implants	2001	—

Also cleared against K980620: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 18 years and passes through 7 companies; a new generation was cleared every 11 months on median.
11 of the 135 ancestors have a recall of any class.
2 other devices also cite its predicate K980620.

How does its category compare?

All DZE devices

DZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · DZE

31in 2025

2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007high 265 (2014) · low 107 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DZE

1in 2025

2007high 15 (2016) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DZE

465,788in 2025

2007high 537,585 (2023) · low 164 (2009)2025

MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	43	107	11	225
2008	61	118	4	393
2009	41	110	3	164
2010	34	162	3	360
2011	26	194	0	362
2012	39	174	11	358
2013	42	195	1	391
2014	36	265	7	1,124
2015	36	215	3	2,894
2016	40	219	15	1,116
2017	48	223	4	9,719
2018	41	200	4	12,892
2019	31	231	8	167,016
2020	41	230	0	255,524
2021	34	182	6	479,618
2022	34	243	0	483,224
2023	35	248	0	537,585
2024	40	222	1	473,629
2025	31	184	1	465,788
2026	15	194	2	—

What is it indicated for?

These devices are intended for intra-bony and inter-radicular transitional applications, to permit immediate splinting stability and ongoing fixation of new or existing crown and bridge installations for full or partial edlentualism such as: Support anchors for temporary restorations during the healing and osseointegration process of permanent implants, Immediate loading temporary abutments for repairing failing tooth and implant supported restorations…

Read the full statement (186 words)

Support anchors for temporary restorations during the healing and osseointegration process of permanent implants,

Immediate loading temporary abutments for repairing failing tooth and implant supported restorations,

Transitional supports for immediate replacement of missing teeth,

For use in front maxilla where 4 or more implants are splinted together, may be loaded immediately.

This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.

This device is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It may be used for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072917 · printed Nov 5, 2026

Cite this page

510(k) Report. “K072917: JJG Evolution Orthodontic Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072917

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026