510(k) · Cleared
ClearedVITA ENAMIC Implant Solutions (IS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vita Zahnfabrik H.Rauter GmbH Co. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jun 30, 2016 as substantially equivalent to K111421 (Sirona Dental Systems GmbH, 2012) and 2 other predicates after a 192-day review. Its family tree reaches back 12 generations to 1990.
- Decided
- Jun 30, 2016
- Review
- 192 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K894844 (1990). 129 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 12 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 8 generations between
- 3 generations backK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- 2 generations backK111421 Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH · 2012
- 1 generation backK132209 Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG · 2013
- This deviceK153645 VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co. · 2016
Show all 12 generations
- Root · 12 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 11 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 10 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 9 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 8 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 7 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 6 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 5 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 4 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 3 generations backK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- 2 generations backK111421 Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH · 2012
- 1 generation backK132209 Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG · 2013
- This deviceK153645 VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −11 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −10 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −9 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −8 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −7 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −6 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −5 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −4 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −3 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
| −2 | K111421 | Sirona Dental Cad/Cam System | Sirona Dental Systems GmbH | 2012 | — |
| −1 | K132209 | Ips E.Max Cad Abutment Solutions | Ivoclar Vivadent, AG | 2013 | — |
| 0 (this device) | K153645 | VITA ENAMIC Implant Solutions (IS) | Vita Zahnfabrik H.Rauter GmbH Co. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 11 | 0 |
| 1994 | 10 | 0 |
| 1995 | 8 | 0 |
| 1996 | 10 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 10 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 7 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K111421 | Sirona Dental Cad/Cam SystemSummary page 5…l Implant Abutment Regulation Number 21 CFR 872.3630 Product Code NHA Predicate Devices inCoris ZI meso (Sirona Dental) – K111421 – Primary Predicate VITA ENAMIC® (VITA Zahnfabrik GmbH) – K122269 IPS e.max® CAD Abutment Solutions (Ivoclar Vivade… | 2012 |
| * | K122269 | EnamicSummary page 5… Product Code NHA Predicate Devices inCoris ZI meso (Sirona Dental) – K111421 – Primary Predicate VITA ENAMIC® (VITA Zahnfabrik GmbH) – K122269 IPS e.max® CAD Abutment Solutions (Ivoclar Vivadent) – K132209 VITA ENAMIC® IS - 510(k) Premarket Notification… | 2012 |
| * | K132209 | Ips E.Max Cad Abutment SolutionsSummary page 5…ZI meso (Sirona Dental) – K111421 – Primary Predicate VITA ENAMIC® (VITA Zahnfabrik GmbH) – K122269 IPS e.max® CAD Abutment Solutions (Ivoclar Vivadent) – K132209 VITA ENAMIC® IS - 510(k) Premarket Notification Page 1 Device Descript… | 2013 |
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 26 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 18 of the 129 ancestors have a recall of any class.
- 6 other devices also cite its predicate K111421.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
VITA ENAMIC Implant Solutions is indicated for use as a component of a two-piece abutment system, consisting of a tibase component, and a mesostructure or abutment crown. VITA ENAMIC Implant Solutions is intended for use in partially or fully edentulous mandible or maxillae for fabrication of permanent, anterior or posterior, single unit CAD/CAM abutments. VITA ENAMIC Implant Solutions is indicated for use in conjunction with the CAD/CAM component of the…
Read the full statement (595 words)
VITA ENAMIC Implant Solutions is indicated for use as a component of a two-piece abutment system, consisting of a tibase component, and a mesostructure or abutment crown. VITA ENAMIC Implant Solutions is intended for use in partially or fully edentulous mandible or maxillae for fabrication of permanent, anterior or posterior, single unit CAD/CAM abutments. VITA ENAMIC Implant Solutions is indicated for use in conjunction with the CAD/CAM component of the Sirona Dental CAD/CAM system and the following Tibase abutments and implant bodies:
Table 1 – Compatible Sirona Ti Base/Implant System and VITA ENAMIC IS Interface
Sirona TiBase Type | Abutment Screw | Sirona Part # | VITA ENAMIC IS Interface | Implant Manufacturer | Implant System | Implant Diameter
NBRS 3.5 | M1.8 | 6282474 | L | Nobel Biocare | Replace® NP | 3.5 mm
NBRS 4.3 | M2 | 6282482 | L | Nobel Biocare | Replace® RP | 4.3 mm
NBRS 5.0 | M2 | 6282490 | L | Nobel Biocare | Replace® WP | 5.0 mm
NBRS 6.0 | M2 | 6282508 | L | Nobel Biocare | Replace® 6.0 | 6.0 mm
NBB 3.4 | M1.6 | 6282516 | L | Nobel Biocare | Brånemark® | 3.3 mm
NBB 4.1 | M2 | 6282524 | L | Nobel Biocare | Brånemark® | 3.75 / 4.0 mm
NB A 4.5 | M1.6 | 6308188 | L | Nobel Biocare | Nobel Active NP | 3.5 mm
NB A 5.0 | M2 | 6308253 | L | Nobel Biocare | Nobel Active RP | 4.3 / 5.0 mm
SSO 3.5 | M1.8 | 6284231 | L | Straumann® | Tissue level NN | 3.5 mm
SSO 4.8 | M2 | 6284249 | L | Straumann® | Tissue Level RN | 4.8 mm
SSO 6.5 | M2 | 6284256 | L | Straumann® | Tissue Level WN | 6.5 mm
S BL 3.3 | M1.6 | 6308154 | L | Straumann® | Bone Level NC | 3.3mm
S BL 4.1 | M1.6 | 6308337 | L | Straumann® | Bone Level NC | 4.1 / 4.8 mm
ATOS 3.5/4.0 | M1.6 | 6282532 | L | Astra Tech | OsseoSpeed™ | 3.5 S/4.0 S mm
ATOS 4.5/5.0 | M1.6 | 6282540 | L | Astra Tech | OsseoSpeed™ | 4.5 / 5.0 mm
FX 3.4 | M1.6 | 6282433 | S | Friadent | Frialit®Xive® | 3.4 mm
FX 3.8 | M1.6 | 6282441 | S | Friadent | Frialit®Xive® | 3.8 mm
FX 4.5 | M1.6 | 6282458 | L | Friadent | Frialit®Xive® | 4.5 mm
FX 5.5 | M1.6 | 6282466 | L | Friadent | Frialit®Xive® | 5.5 mm
BO 3.4 | M2 | 6282557 | L | Biomet 3i | Ex. hex | 3.4 mm
BO 4.1 | M2 | 6282565 | L | Biomet 3i | Ex. hex | 4.1 mm
BO 5.0 | M2 | 6282573 | L | Biomet 3i | Ex. hex | 5.0 mm
B C 3.4 | M1.6 | 6308048 | S | Biomet 3i | Certain® | 3.5 mm
B C 4.1 | M1.6 | 6308097 | L | Biomet 3i | Certain® | 4.5 mm
B C 5.0 | M1.6 | 6308121 | L | Biomet 3i | Certain® | 5.7 mm
ZTSV 3.5 | M1.8 | 6282581 | L | Zimmer | Tapered screw-Vent® | 3.5 mm
ZTSV 4.5 | M1.8 | 6282599 | L | Zimmer | Tapered screw-Vent® | 4.5 mm
ZTSV 5.7 | M1.8 | 6282607 | L | Zimmer | Tapered screw-Vent® | 5.7 mm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153645 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153645: VITA ENAMIC Implant Solutions (IS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153645
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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