510(k) · Cleared
ClearedSGS Dental Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sgs International, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Nov 21, 2014 as substantially equivalent to K051719 (A.B. Dental Devices, Ltd., 2006) and 8 other predicates after a 385-day review. Its family tree reaches back 15 generations to 1996. 2 later devices descend from it.
- Decided
- Nov 21, 2014
- Review
- 385 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 15 generations to K960026 (1996). 260 ancestors in all, the oldest K781060 (1978). 2 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 11 generations between
- 3 generations backK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- 2 generations backK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- 1 generation backK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- This deviceK133362 SGS Dental ImplantSgs International, Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK182219 SGS Dental Implants SystemSgs International, Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK182143 ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd. · 2019
Show all 15 generations
- Root · 15 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 14 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 13 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 12 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 11 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 10 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 9 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 8 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 7 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 6 generations backK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- 5 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 4 generations backK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- 3 generations backK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- 2 generations backK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- 1 generation backK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- This deviceK133362 SGS Dental ImplantSgs International, Ltd. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −14 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −13 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −12 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −11 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −10 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −9 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −8 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −7 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −6 | K052419 | Maximus 3.0 and OS Implants | BioHorizons Implant Systems, Inc. | 2005 | — |
| −5 | K093321 | Biohorizons Laser-Lok 3.0 Implant System | BioHorizons Implant Systems, Inc. | 2010 | 1 |
| −4 | K100985 | Biohorizons Simple Solutions with Laser-Lok | BioHorizons Implant Systems, Inc. | 2010 | — |
| −3 | K103691 | Biohorizons Abutments for Zimmer | BioHorizons Implant Systems, Inc. | 2011 | 1 |
| −2 | K112440 | AB Dental Devices Implants and Accessories | A.B. Dental Devices, Ltd. | 2012 | — |
| −1 | K132125 | A.B. Dental Devices Dental Implants System | A.B. Dental Devices, Ltd. | 2014 | — |
| 0 (this device) | K133362 | SGS Dental Implant | Sgs International, Ltd. | 2014 | — |
| +1 | K182219 | SGS Dental Implants System | Sgs International, Ltd. | 2019 | — |
| +2 | K182143 | ALFA GATE Dental Implants System | Alfa Gate Mazen, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 4 | 0 |
| 1986 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 4 | 0 |
| 1992 | 4 | 0 |
| 1993 | 12 | 0 |
| 1994 | 13 | 0 |
| 1995 | 12 | 0 |
| 1996 | 14 | 0 |
| 1997 | 6 | 0 |
| 1998 | 9 | 0 |
| 1999 | 13 | 0 |
| 2000 | 9 | 0 |
| 2001 | 13 | 0 |
| 2002 | 15 | 0 |
| 2003 | 15 | 0 |
| 2004 | 16 | 0 |
| 2005 | 9 | 0 |
| 2006 | 16 | 0 |
| 2007 | 14 | 0 |
| 2008 | 10 | 0 |
| 2009 | 9 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
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
What was it cleared against? (9)
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 | Decided |
|---|---|---|---|
| * | K051719 | A.B. Dental DevicesSummary page 5…: New Device 8 Identification of Legally Marketed Predicate Devices : SGS® Dental Implants System is substantially equivalent to A.B.Dental Devices ltd K051719, K112440, K132125; M.I.S, K092555, K040807,K103089; Alpha Bio Tec K063364; Nobel Active Multi Unit Abutment K072570; DIO Biot… | 2006 |
| * | K112440 | AB Dental Devices Implants and AccessoriesSummary page 5…New Device 8 Identification of Legally Marketed Predicate Devices : SGS® Dental Implants System is substantially equivalent to A.B.Dental Devices ltd K051719, K112440, K132125; M.I.S, K092555, K040807,K103089; Alpha Bio Tec K063364; Nobel Active Multi Unit Abutment K072570; DIO Biotite-H Imp… | 2012 |
| * | K132125 | A.B. Dental Devices Dental Implants System Cleared while this submission was under review Summary page 5…ce 8 Identification of Legally Marketed Predicate Devices : SGS® Dental Implants System is substantially equivalent to A.B.Dental Devices ltd K051719, K112440, K132125; M.I.S, K092555, K040807,K103089; Alpha Bio Tec K063364; Nobel Active Multi Unit Abutment K072570; DIO Biotite-H Implant Syst… | 2014 |
| * | K092555 | Uno Narrow ImplantSummary page 5…ation of Legally Marketed Predicate Devices : SGS® Dental Implants System is substantially equivalent to A.B.Dental Devices ltd K051719, K112440, K132125; M.I.S, K092555, K040807,K103089; Alpha Bio Tec K063364; Nobel Active Multi Unit Abutment K072570; DIO Biotite-H Implant Systems K073070;… | 2010 |
| * | K040807 | Mis Dental Implant SystemSummary page 5…Legally Marketed Predicate Devices : SGS® Dental Implants System is substantially equivalent to A.B.Dental Devices ltd K051719, K112440, K132125; M.I.S, K092555, K040807,K103089; Alpha Bio Tec K063364; Nobel Active Multi Unit Abutment K072570; DIO Biotite-H Implant Systems K073070; in terms… | 2004 |
| * | K103089 | Seven Implants; Biocom Implants; Lance ImplantsSummary page 5…Marketed Predicate Devices : SGS® Dental Implants System is substantially equivalent to A.B.Dental Devices ltd K051719, K112440, K132125; M.I.S, K092555, K040807,K103089; Alpha Bio Tec K063364; Nobel Active Multi Unit Abutment K072570; DIO Biotite-H Implant Systems K073070; in terms of inte… | 2011 |
| * | K063364 | Alpha Bio Dental Implant SystemSummary page 5…: SGS® Dental Implants System is substantially equivalent to A.B.Dental Devices ltd K051719, K112440, K132125; M.I.S, K092555, K040807,K103089; Alpha Bio Tec K063364; Nobel Active Multi Unit Abutment K072570; DIO Biotite-H Implant Systems K073070; in terms of intended use, indication for us… | 2007 |
| * | K072570 | Nobelactive Multi Unit AbutmentSummary page 5…antially equivalent to A.B.Dental Devices ltd K051719, K112440, K132125; M.I.S, K092555, K040807,K103089; Alpha Bio Tec K063364; Nobel Active Multi Unit Abutment K072570; DIO Biotite-H Implant Systems K073070; in terms of intended use, indication for use, technological characteristics, perf… | 2007 |
| * | K073070 | Dio Biotite-H Implant SystemSummary page 5…td K051719, K112440, K132125; M.I.S, K092555, K040807,K103089; Alpha Bio Tec K063364; Nobel Active Multi Unit Abutment K072570; DIO Biotite-H Implant Systems K073070; in terms of intended use, indication for use, technological characteristics, performance and user interface. The predica… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182219 | SGS Dental Implants System | 2019 | 1 |
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 3 companies; a new generation was cleared every 9 months on median.
- 33 of the 260 ancestors have a recall of any class.
- Of its descendants, K182219 (Sgs International, Ltd., 2019) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K051719.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 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?
SGS® Dental Implants System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. SGS® Dental Implants System may be immediate loading when good primary stability is achieved and with appropriate occlusal loading. Two Stage Implants: P1, P7, P7N. One Stage: P7S, P9S. One Stage & One-Piece 3.0 mm diameter implants: P7S, P9S are intended for…
Read the full statement (129 words)
SGS® Dental Implants System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. SGS® Dental Implants System may be immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Two Stage Implants: P1, P7, P7N.
One Stage: P7S, P9S.
One Stage & One-Piece 3.0 mm diameter implants: P7S, P9S are intended for placement at the mandibular central and lateral incisors and maxillary and lateral incisors. Indicated also for denture stabilization using multiple implants.
One stage & One-Piece 2.4 mm diameter implants for temporary use or long term use: P9S permit immediate splint stability and long term fixation of new or existing crown, bridge and prosthesis.
PEEK Temporary Abutments are for 30 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133362: SGS Dental Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133362
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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