# K153645: VITA ENAMIC Implant Solutions (IS)

- Pathway: 510(k) (Abbreviated)
- Applicant: Vita Zahnfabrik H.Rauter GmbH Co.
- Decided: Jun 30, 2016 after 192 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K894844 (1990). 129 ancestors in all.
No later device cites it as a predicate yet.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111421: Sirona Dental Cad/Cam System, Sirona Dental Systems GmbH (2012) Summary page 5.
- K122269: Enamic, Vita Zahnfabrik H.Rauter GmbH & Co. (2012) Summary page 5.
- K132209: Ips E.Max Cad Abutment Solutions, Ivoclar Vivadent, AG (2013) Summary page 5.

## Indications for use
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

Source page: https://510kreport.com/device/K153645
Methodology: https://510kreport.com/methodology