510(k) · Cleared
ClearedPlastic Protection Healing Caps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Straumann Co. · DZE Implant, Endosseous, Root-Form
Cleared on Aug 15, 1996 as substantially equivalent to K925780 (Nobelpharma USA, Inc., 1993) and 1 other predicate after an 84-day review. Its family tree reaches back 1 generation to 1992. 349 later devices descend from it.
- Decided
- Aug 15, 1996
- Review
- 84 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K912734 (1992). 2 ancestors in all. 349 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK912734 Interpore Hex Head Implant Restorative ComponentsInterpore Intl. · 1992
- This deviceK962023 Plastic Protection Healing CapsThe Straumann Co. · 1996
- Descendant · cites it directly · 318 of its ownK051717 RN Synocta Temporary Meso AbutmentInstitut Straumann SA · 2005
- Descendant · 2 generations on · 283 of its ownK070478 P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Straumann Manufacturing, Inc. · 2007
- Descendant · 3 generations on · 279 of its ownK072679 P.004 AbutmentsInstitut Straumann AG · 2007
- Descendant · 4 generations on · 223 of its ownK092814 Straumann Dental AbutmentsStraumann Manufacturing, Inc. · 2009
- Descendant · 5 generations on · 222 of its ownK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
Showing 5 of 349 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 349 · See all- K051717RN Synocta Temporary Meso AbutmentInstitut Straumann SA · 2005 · cites it directly318descendants
- K070478P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Straumann Manufacturing, Inc. · 2007 · 2 generations on283descendants
- K072679P.004 AbutmentsInstitut Straumann AG · 2007 · 3 generations on279descendants
- K092814Straumann Dental AbutmentsStraumann Manufacturing, Inc. · 2009 · 4 generations on223descendants
- K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011 · 5 generations on222descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912734 | Interpore Hex Head Implant Restorative Components | Interpore Intl. | 1992 | — |
| 0 (this device) | K962023 | Plastic Protection Healing Caps | The Straumann Co. | 1996 | — |
| +1 | K051717 | RN Synocta Temporary Meso Abutment | Institut Straumann SA | 2005 | — |
| +2 | K070478 | P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap) | Straumann Manufacturing, Inc. | 2007 | — |
| +3 | K072679 | P.004 Abutments | Institut Straumann AG | 2007 | — |
| +4 | K092814 | Straumann Dental Abutments | Straumann Manufacturing, Inc. | 2009 | — |
| +5 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 8 | 0 |
| 2014 | 10 | 0 |
| 2015 | 14 | 0 |
| 2016 | 16 | 0 |
| 2017 | 22 | 0 |
| 2018 | 22 | 0 |
| 2019 | 13 | 0 |
| 2020 | 28 | 0 |
| 2021 | 28 | 0 |
| 2022 | 25 | 0 |
| 2023 | 47 | 0 |
| 2024 | 45 | 0 |
| 2025 | 30 | 0 |
| 2026 | 19 | 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? (4)
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 |
|---|---|---|---|
| * | K925780 | Branemark System Healing CapsSummary page 1…y to a dental implant (21 CFR 872.3640) ally Marketed Devices to which Equivalence is Claimed (Predicate Devices) Nobelpharma's Branemark System Healing Caps (K Number 925780) Calcitek's Abutment Comfort Caps (K Number unknown) Interpore International's Abutment Complete Sealing Caps (K Number 912734)… | 1993 |
| * | K912734 | Interpore Hex Head Implant Restorative ComponentsSummary page 1…s Branemark System Healing Caps (K Number 925780) Calcitek's Abutment Comfort Caps (K Number unknown) Interpore International's Abutment Complete Sealing Caps (K Number 912734) Steri-Oss' Healing Cap (K Number unknown) Description of the Device The ITI Protection Healing Cap is a device which is mounte… | 1992 |
| * | — | Calcitek's Abutment Comfort Caps Named without a submission number | |
| * | — | Steri-Oss' Healing Cap Named without a submission number |
What descends from it? (349)
See all 3494 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051717 | RN Synocta Temporary Meso Abutment | 2005 | 318 |
| K072071 | Straumann P.004 Cementable Abutments, Temporary Copings and Protective Caps | 2007 | 205 |
| K080239 | P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent Copings | 2008 | 164 |
| K061169 | Endosseous Dental Implant | 2006 | 24 |
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?
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The intended use of the ITI Protection Healing Caps is to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the prosthetic phase to achieve an esthetic result with the final restoration. The primary indication for the Protection Healing Cap is in the esthetic zone of the oral cavity where soft tissue conditioning is essential to achieve an optimal esthetic result with implant-borne restorations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962023 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962023: Plastic Protection Healing Caps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962023
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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