510(k) · Cleared
ClearedZimmer 3.1MM Dental Implant;2.9MM Angled Abutment;Straight Hex, 2.9MM Contour Abutement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Dental, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Oct 28, 2014 as substantially equivalent to K011028 (Sulzer Dental, Inc., 2001) and 9 other predicates after an 89-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Oct 28, 2014
- Review
- 89 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 8 generations to K894595 (1990). 37 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 5 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 4 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 3 generations backK050705 Tiunite ImplantsNobel Biocare AB · 2005 · Recalled
- 2 generations backK061410 Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System…Zimmer Dental, Inc. · 2006 · Recalled
- 1 generation backK072589 Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and…Zimmer Dental, Inc. · 2007 · Recalled
- This deviceK142082 Zimmer 3.1MM Dental Implant;2.9MM Angled Abutment;Straight Hex…Zimmer Dental, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −5 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −4 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −3 | K050705 | Tiunite Implants | Nobel Biocare AB | 2005 | 1 |
| −2 | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent… | Zimmer Dental, Inc. | 2006 | 1 |
| −1 | K072589 | Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16… | Zimmer Dental, Inc. | 2007 | 3 |
| 0 (this device) | K142082 | Zimmer 3.1MM Dental Implant;2.9MM Angled Abutment;Straight Hex, 2.9MM Contour… | Zimmer Dental, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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? (10)
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 |
|---|---|---|---|
| * | K011028 | Screw-Vent Dental Implant SystemSummary page 6…Predicate Device(s): Predicate Device No. 1 Trade Name: Tapered Screw-Vent Implant 510(k): K011028, K013227, K061410, K072589, K101977, K111889 Regulation Number: 87… | 2001 |
| * | K013227 | Screw Vent Implant; Tapered Screw Vent ImplantSummary page 6…icate Device(s): Predicate Device No. 1 Trade Name: Tapered Screw-Vent Implant 510(k): K011028, K013227, K061410, K072589, K101977, K111889 Regulation Number: 872.3640… | 2001 |
| * | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant…Summary page 6…ice(s): Predicate Device No. 1 Trade Name: Tapered Screw-Vent Implant 510(k): K011028, K013227, K061410, K072589, K101977, K111889 Regulation Number: 872.3640… | 2006 |
| * | K072589 | Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16, TSV4H8, H11…Summary page 6…Predicate Device No. 1 Trade Name: Tapered Screw-Vent Implant 510(k): K011028, K013227, K061410, K072589, K101977, K111889 Regulation Number: 872.3640 Classific… | 2007 |
| * | K101977 | Tapered Screw-Vent T ImplantSummary page 6…Name: Tapered Screw-Vent Implant 510(k): K011028, K013227, K061410, K072589, K101977, K111889 Regulation Number: 872.3640 Classification Code: DZE Device Classif… | 2010 |
| * | K111889 | Zimmer Dental Tapered Screw-Vent M ImplantSummary page 6…Tapered Screw-Vent Implant 510(k): K011028, K013227, K061410, K072589, K101977, K111889 Regulation Number: 872.3640 Classification Code: DZE Device Classification N… | 2011 |
| * | K070184 | Dental Implant, Dental Abutment, Abutment Screw, Cover Screw, Healing AbutmentSummary page 6…t, Endosseous, Root-Form Predicate Device No. 3 Trade Name: Ospol Dental Implant System 510(k): K070184 Regulation Number: 872.3640 Classification Code: DZE Device Classification N… | 2008 |
| * | K052600 | Zimmer Dental Hex-Lock Prepared Abutment (Straight & Angled)Summary page 7…Predicate Device No. 5 Trade Name: Zimmer Dental Inc. 3.5mm Hex-Lock Abutment 510(k): K052600 Regulation Number: 872.3630 Classification Code: NHA Device Cl… | 2005 |
| * | K092377 | Plastic Temporary Abutments, Models: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S…Summary page 7…Predicate Device No. 6 Trade Name: Zimmer Dental Inc. Temporary Plastic Abutment 510(k): K092377 Regulation Number: 872.3630 Classification Code: NHA Device Cl… | 2009 |
| * | K111852 | Anodized Healing CollarSummary page 7…Form Predicate Device No. 8 Trade Name: Zimmer Dental TSV Healing Collars 510(k): K111852 Regulation Number: 872.3630 Classification Code: NHA Device Cl… | 2011 |
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 24 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 11 of the 37 ancestors have a recall of any class.
- 15 other devices also cite its predicate K011028.
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?
Zimmer 3.1mmD Dental Implants are designed for use in the anterior maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Zimmer 3.1mmD Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient…
Read the full statement (442 words)
Zimmer 3.1mmD Dental Implants are designed for use in the anterior maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Zimmer 3.1mmD Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical). The Zimmer 3.1mmD Dental Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.
The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are used for attachment of restorations requiring off-axis correction. The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are designed to be used in edentulous or partially 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 freestanding single tooth replacement.
The 2.9mm Contour Abutment and the 2.9mm Contour Abutment, Straight Hex are used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a single- or multiple-unit restoration. The 2.9mm Angled Contour Abutment and the 2.9mm Angled Contour Abutment, Straight Hex are designed to be used as a terminal or intermediate abutment for a cemented prosthesis where the angle needs to be offset by 17°. Abutment can be used for a single- or multiple-unit restoration.
The 2.9mm Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The 2.9mm Temporary Abutment can be used for cement-retained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations.
The Ball Abutment is used for retaining overdentures or partial dentures when resilience and facilitated oral hygiene are desired.
The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only.
The Healing Screw is used to seal the implant internal connection and separate it from the soft tissue which is sutured over the implant during healing.
The Retaining Screws are intended to be used for securing the temporary abutments, final abutments and impression transfers to the implant or implant analog. The long Retaining Screw is intended to be used with Temporary Abutments for fabrication of screw-retained provisional restorations and with Impression Transfers for direct impressions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142082 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142082: Zimmer 3.1MM Dental Implant;2.9MM Angled Abutment;Straight Hex, 2.9MM Contour Abutement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142082
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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