510(k) Report

510(k) · Cleared

Cleared

Easy Grip Dental Implant System

K073622510(k) TraditionalCleared May 14, 2008140-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

T.F.I. System S.R.L · DZE Implant, Endosseous, Root-Form

Cleared on May 14, 2008 as substantially equivalent to K033922 (Institut Straumann AG, 2004) and 15 other predicates after a 140-day review. Its family tree reaches back 9 generations to 1990.

Decided
May 14, 2008
Review
140 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
16

Its longest line of descent runs back 9 generations to K894595 (1990). 114 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestor2006: 1 other ancestor2004: 6 other ancestors2003: 11 other ancestors2002: 10 other ancestors2001: 8 other ancestors2005: 2 other ancestors1999: 4 other ancestors1998: 4 other ancestors1997: 5 other ancestors1996: 11 other ancestors1995: 6 other ancestors1994: 6 other ancestors1993: 3 other ancestors1988: 1 other ancestor2000: 5 other ancestors1990: 6 other ancestors1989: 5 other ancestors1987: 2 other ancestors1986: 2 other ancestors1992: 3 other ancestors1985: 1 other ancestor1982: 1 other ancestor1978: 1 other ancestorK894595 · Bonefit R Screw Implants · Institut Straumann AG · 1990K984104 · Iti Dental Implant System · Straumann USA · 1999 · recalledK992937 · Dental Implant · Nobel Biocare Uas, Inc. · 2000 · recalled×2: 2 generations cleared close together, K013067 (2002), K021318 (2002) K032158 · Xive Dental Implant System Multiple · Friadent GmbH · 2003K033984 · Straumann Dental Implant System · Institut Straumann AG · 2004K040757 · Sic Pro · Sic Invent AG · 2005K061500 · Sicace Dental Implant System and Sic Angled Abutments · Sic Invent AG · 200619751980198519901995200020052010
Other ancestors, by generation 1 generation back: 12 other ancestors2 generations back: 32 other ancestors3 generations back: 36 other ancestors4 generations back: 20 other ancestors5 generations back: 4 other ancestors6 generations back: 1 other ancestor K061500 · Sicace Dental Implant System and Sic Angled Abutments · Sic Invent AG · 2006K040757 · Sic Pro · Sic Invent AG · 2005K033984 · Straumann Dental Implant System · Institut Straumann AG · 2004K032158 · Xive Dental Implant System Multiple · Friadent GmbH · 2003K021318 · Xive Dental Implant System · Friadent GmbH · 2002K013067 · Frialoc Dental Implant System · Friadent GmbH · 2002K992937 · Dental Implant · Nobel Biocare Uas, Inc. · 2000 · recalledK984104 · Iti Dental Implant System · Straumann USA · 1999 · recalledK894595 · Bonefit R Screw Implants · Institut Straumann AG · 1990−50
  1. Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
  2. 5 generations between
  3. 3 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
  4. 2 generations backK040757 Sic ProSic Invent AG · 2005
  5. 1 generation backK061500 Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG · 2006
  6. This deviceK073622 Easy Grip Dental Implant SystemT.F.I. System S.R.L · 2008
Show all 9 generations
  1. Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
  2. 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
  3. 7 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
  4. 6 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
  5. 5 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
  6. 4 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
  7. 3 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
  8. 2 generations backK040757 Sic ProSic Invent AG · 2005
  9. 1 generation backK061500 Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG · 2006
  10. This deviceK073622 Easy Grip Dental Implant SystemT.F.I. System S.R.L · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K894595Bonefit R Screw ImplantsInstitut Straumann AG1990—
−8K984104Iti Dental Implant SystemStraumann USA19991
−7K992937Dental ImplantNobel Biocare Uas, Inc.20001
−6K013067Frialoc Dental Implant SystemFriadent GmbH2002—
−5K021318Xive Dental Implant SystemFriadent GmbH2002—
−4K032158Xive Dental Implant System MultipleFriadent GmbH2003—
−3K033984Straumann Dental Implant SystemInstitut Straumann AG2004—
−2K040757Sic ProSic Invent AG2005—
−1K061500Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG2006—
0 (this device)K073622Easy Grip Dental Implant SystemT.F.I. System S.R.L2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198210
198510
198620
198720
198810
198950
199060
199230
199330
199460
199560
1996110
199750
199840
199940
200050
200180
2002100
2003110
200460
200520
200610
200710
FIG. 1 — Lineage of K073622, 1990–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (16)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K033922Modification to Iti Dental Implant System
Summary page 1
…D. Product Code: DZE LEGALLY MARKETED DEVICES (PREDICATE DEVICES) - Straumann USA & AG, ITI® Dental Implant Systems K033922, K984104, K003271, K012757,1K030007,K031055, - Sudimplant SA, T.B.R.® ide@ conic, K050956,…
Institut Straumann AG20041
*K984104Iti Dental Implant System
Summary page 1
…Product Code: DZE LEGALLY MARKETED DEVICES (PREDICATE DEVICES) - Straumann USA & AG, ITI® Dental Implant Systems K033922, K984104, K003271, K012757,1K030007,K031055, - Sudimplant SA, T.B.R.® ide@ conic, K050956,…
Straumann USA19991
*K003271Modification to Iti Dental Implant System
Summary page 1
…oduct Code: DZE LEGALLY MARKETED DEVICES (PREDICATE DEVICES) - Straumann USA & AG, ITI® Dental Implant Systems K033922, K984104, K003271, K012757,1K030007,K031055, - Sudimplant SA, T.B.R.® ide@ conic, K050956, - A…
Institut Straumann AG2001—
*K012757Iti Dental Implant System
Summary page 1
…LEGALLY MARKETED DEVICES (PREDICATE DEVICES) - Straumann USA & AG, ITI® Dental Implant Systems K033922, K984104, K003271, K012757,1K030007,K031055, - Sudimplant SA, T.B.R.® ide@ conic, K050956, - ACE Surgical Supply Co., Inc.…
Straumann USA2001—
*K030007Iti Dental Implant System
Summary page 1
…LEGALLY MARKETED DEVICES (PREDICATE DEVICES) - Straumann USA & AG, ITI® Dental Implant Systems K033922, K984104, K003271, K012757,1K030007,K031055, - Sudimplant SA, T.B.R.® ide@ conic, K050956, - ACE Surgical Supply Co., Inc., ACE CON…
Straumann USA2003—
*K031055Iti Dental Implant System
Summary page 1
…Y MARKETED DEVICES (PREDICATE DEVICES) - Straumann USA & AG, ITI® Dental Implant Systems K033922, K984104, K003271, K012757,1K030007,K031055, - Sudimplant SA, T.B.R.® ide@ conic, K050956, - ACE Surgical Supply Co., Inc., ACE CONNECT TM…
Straumann USA2003—
*K050956TBR Idea Conic/Conic
Summary page 1
…umann USA & AG, ITI® Dental Implant Systems K033922, K984104, K003271, K012757,1K030007,K031055, - Sudimplant SA, T.B.R.® ide@ conic, K050956, - ACE Surgical Supply Co., Inc., ACE CONNECT TM Internal Connection Screw Dental Implant Sys…
Sudimplant SA2006—
*K041759Ace Connect Internal Connection
Summary page 1
…lant SA, T.B.R.® ide@ conic, K050956, - ACE Surgical Supply Co., Inc., ACE CONNECT TM Internal Connection Screw Dental Implant System K041759, - Implant Innovations, Inc., 3i Restorative Dental Implant Systems, K041402, K063286, K02200…
Ace Surgical Supply Co., Inc.2004—
*K041402Modification to Osseotite NT Certain Implants
Summary page 1
…NNECT TM Internal Connection Screw Dental Implant System K041759, - Implant Innovations, Inc., 3i Restorative Dental Implant Systems, K041402, K063286, K022009, - SIC Invent AG, SIC Dental Implant Systems, K040757, K061 500,…
Implant Innovations, Inc.2004—
*K063286Osseotite; Osseotite NT; XP; TG Osseotite
Summary page 1
…Internal Connection Screw Dental Implant System K041759, - Implant Innovations, Inc., 3i Restorative Dental Implant Systems, K041402, K063286, K022009, - SIC Invent AG, SIC Dental Implant Systems, K040757, K061 500, -…
Implant Innovations, Inc.20075
*K0220093I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants
Summary page 1
…ntal Implant System K041759, - Implant Innovations, Inc., 3i Restorative Dental Implant Systems, K041402, K063286, K022009, - SIC Invent AG, SIC Dental Implant Systems, K040757, K061 500, - FRIADENT GmbH, XIVEO Dental…
Implant Innovations, Inc.2002—
*K040757Sic Pro
Summary page 1
…ant Innovations, Inc., 3i Restorative Dental Implant Systems, K041402, K063286, K022009, - SIC Invent AG, SIC Dental Implant Systems, K040757, K061 500, - FRIADENT GmbH, XIVEO Dental Implant Systems, K013867, K021 318, K024004…
Sic Invent AG2005—
*K061500Sicace Dental Implant System and Sic Angled Abutments
Summary page 1
…ations, Inc., 3i Restorative Dental Implant Systems, K041402, K063286, K022009, - SIC Invent AG, SIC Dental Implant Systems, K040757, K061 500, - FRIADENT GmbH, XIVEO Dental Implant Systems, K013867, K021 318, K024004…
Sic Invent AG2006—
*K013867Xive Dental Implant System
Summary page 1
…K022009, - SIC Invent AG, SIC Dental Implant Systems, K040757, K061 500, - FRIADENT GmbH, XIVEO Dental Implant Systems, K013867, K021 318, K024004 EASY GRIP 510(k) Page 13-2…
Friadent GmbH2002—
*K021318Xive Dental Implant System
Summary page 1
…K022009, - SIC Invent AG, SIC Dental Implant Systems, K040757, K061 500, - FRIADENT GmbH, XIVEO Dental Implant Systems, K013867, K021 318, K024004 EASY GRIP 510(k) Page 13-2 === Page 2…
Friadent GmbH2002—
*K024004Xive Transgingival Dental Implant System
Summary page 1
…2009, - SIC Invent AG, SIC Dental Implant Systems, K040757, K061 500, - FRIADENT GmbH, XIVEO Dental Implant Systems, K013867, K021 318, K024004 EASY GRIP 510(k) Page 13-2 T.F.…
Friadent GmbH2003—

Also cleared against K033922: 9 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 6 companies; a new generation was cleared every 1.1 years on median.
  • 13 of the 114 ancestors have a recall of any class.
  • 9 other devices also cite its predicate K033922.

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

2007: 432008: 612009: 412010: 342011: 262012: 392013: 422014: 362015: 362016: 402017: 482018: 412019: 312020: 412021: 342022: 342023: 352024: 402025: 312026 (partial year): 15
2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007: 107 days median2008: 118 days median2009: 110 days median2010: 162 days median2011: 194 days median2012: 174 days median2013: 195 days median2014: 265 days median2015: 215 days median2016: 219 days median2017: 223 days median2018: 200 days median2019: 231 days median2020: 230 days median2021: 182 days median2022: 243 days median2023: 248 days median2024: 222 days median2025: 184 days median2026 (partial year): 194 days median
2007high 265 (2014) · low 107 (2007)2026

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

Recalls per year · DZE

1in 2025

2007: 112008: 42009: 32010: 32012: 112013: 12014: 72015: 32016: 152017: 42018: 42019: 82021: 62024: 12025: 12026 (partial year): 2
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

2007: 2252008: 3932009: 1642010: 3602011: 3622012: 3582013: 3912014: 1,1242015: 2,8942016: 1,1162017: 9,7192018: 12,8922019: 167,0162020: 255,5242021: 479,6182022: 483,2242023: 537,5852024: 473,6292025: 465,788
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074310711225
2008611184393
2009411103164
2010341623360
2011261940362
20123917411358
2013421951391
20143626571,124
20153621532,894
201640219151,116
20174822349,719
201841200412,892
2019312318167,016
2020412300255,524
2021341826479,618
2022342430483,224
2023352480537,585
2024402221473,629
2025311841465,788
2026151942—

What is it indicated for?

EASY GRIP implants are designed for use in partially or totally edentulous mandibles or maxillae for attachment of complete denture prostheses or as a terminal or intermediary abutment for fixed or removable bridgework or as a free-standing single tooth replacement. EASY GRIP implant system uses a two-stage implantation procedure or one-stage procedure.

Indications for use as stated in the FDA summary.

Also cleared against K033922

9 other devices cite the same predicate.

  • K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC · 20152 recalls
  • K133733WINSIX Implant SystemBiosaf IN S.R.L. · 2015
  • K130222Straumann Dental Implant SystemStraumann USA, LLC · 2013
  • K123784Straumann Dental Implant SystemStraumann USA, LLC · 2013
  • K122855TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental ImplantsStraumann USA · 2012
  • K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011

Recent decisions in DZE

The DZE category page

  • K261295MultiNeO Dental Implant SystemAlpha Bio Tec, Ltd. · 2026
  • K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026
  • K260463ZEROS Dental Implant SystemZeros Co., Ltd. · 2026
  • K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd. · 2026
  • K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd. · 2026

https://510kreport.com/device/K073622 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073622: Easy Grip Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073622

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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