510(k) · Cleared
Recalled · Class II · 2017Screw Vent Implant; Tapered Screw Vent Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sulzer Dental, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Nov 19, 2001 as substantially equivalent to K992937 (Nobel Biocare Uas, Inc., 2000) and 3 other predicates after a 53-day review. Its family tree reaches back 3 generations to 1990. 305 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 19, 2001
- Review
- 53 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 3 generations to K894595 (1990). 12 ancestors in all. 305 later devices descend from it, 15 citing it directly.
- Root · 3 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 2 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 1 generation backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- This deviceK013227 Screw Vent Implant; Tapered Screw Vent ImplantSulzer Dental, Inc. · 2001
- Descendant · cites it directly · 187 of its ownK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- Descendant · 2 generations on · 141 of its ownK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- Descendant · 3 generations on · 127 of its ownK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- Descendant · 4 generations on · 123 of its ownK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- Descendant · cites it directly · 122 of its ownK061410 Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System…Zimmer Dental, Inc. · 2006 · Recalled
Showing 5 of 305 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 305 · See all- K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007 · cites it directly187descendants
- K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · 2 generations on141descendants
- K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013 · 3 generations on127descendants
- K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014 · 4 generations on123descendants
- K061410Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant…Zimmer Dental, Inc. · 2006 · cites it directly122descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −2 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −1 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| 0 (this device) | K013227 | Screw Vent Implant; Tapered Screw Vent Implant | Sulzer Dental, Inc. | 2001 | — |
| +1 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| +2 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| +3 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| +4 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| +1 | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent… | Zimmer Dental, Inc. | 2006 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 7 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 11 | 0 |
| 2012 | 8 | 0 |
| 2013 | 18 | 0 |
| 2014 | 16 | 0 |
| 2015 | 15 | 0 |
| 2016 | 12 | 0 |
| 2017 | 8 | 0 |
| 2018 | 11 | 0 |
| 2019 | 15 | 0 |
| 2020 | 19 | 0 |
| 2021 | 18 | 0 |
| 2022 | 25 | 0 |
| 2023 | 28 | 0 |
| 2024 | 26 | 0 |
| 2025 | 30 | 0 |
| 2026 | 17 | 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 |
|---|---|---|---|
| * | K992937 | Dental ImplantSummary page 1…ewVent® and Tapered ScrewVent® The primary devices used for comparison in this summary are the dental implants and indications for use clear under the Branemark System (K992937 and K993595) and the ITI implants (K984104 and K002374). 1. Intended Use: Sulzer Dental’s implant systems are designed for use… | 2000 |
| * | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement)Summary page 1…Tapered ScrewVent® The primary devices used for comparison in this summary are the dental implants and indications for use clear under the Branemark System (K992937 and K993595) and the ITI implants (K984104 and K002374). 1. Intended Use: Sulzer Dental’s implant systems are designed for use in edentulou… | 2000 |
| * | K984104 | Iti Dental Implant SystemSummary page 1…devices used for comparison in this summary are the dental implants and indications for use clear under the Branemark System (K992937 and K993595) and the ITI implants (K984104 and K002374). 1. Intended Use: Sulzer Dental’s implant systems are designed for use in edentulous mandibles or maxillae for att… | 1999 |
| * | K002374 | Iti Dental Implant System Monotype ImplantSummary page 1…d for comparison in this summary are the dental implants and indications for use clear under the Branemark System (K992937 and K993595) and the ITI implants (K984104 and K002374). 1. Intended Use: Sulzer Dental’s implant systems are designed for use in edentulous mandibles or maxillae for attachment of c… | 2000 |
What descends from it? (305)
See all 30515 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063364 | Alpha Bio Dental Implant System | 2007 | 187 |
| K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant… | 2006 | 122 |
| K072589 | Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16, TSV4H8, H11… | 2007 | 98 |
| K101880 | Tapered Screw-Vent T Implant, Tapered Screw-Vent P Implant | 2010 | 94 |
| K112160 | Tapered Screw-Vent X Implant | 2011 | 88 |
| K100985 | Biohorizons Simple Solutions with Laser-Lok | 2010 | 73 |
| K032774 | Renova Internal Hex Implant System | 2003 | 49 |
| K073161 | Replus Dental Implants (HA) | 2008 | 43 |
| K133339 | Zimmer Dental Tapered Screw Vent T Implant, HA Coated;Zimmer Dental Tapered Screw-Vent M… | 2014 | 3 |
| K063106 | Revois Implant System | 2007 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 10, 2017 | Class II | Z-3206-2017 | Under Investigation by firm | Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs. |
| Jul 17, 2014 | Class II | Z-2144-2014 | Process design | Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm." |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K063364 (Alpha-Bio Tec, Ltd., 2007) has gone furthest, with 187 descendants of its own.
- 6 other devices also cite its predicate K992937.
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 ScrewVent and Tapered ScrewVent implants are intended for surgical implantation 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.
In patients with an edentulous mandible, ScrewVent and Tapered ScrewVent implants may be loaded immediately when at least four implants are placed between the mental foramina and rigidly splinted with a bar.
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/K013227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013227: Screw Vent Implant; Tapered Screw Vent Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013227
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026