# K250295: Dentsply Sirona Titanium Bases system

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Apr 30, 2025 after 89 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: 13 generations back to K894844 (1990). 122 ancestors in all.
No later device cites it as a predicate yet.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193408: Sirona Dental CAD/CAM System with CEREC Chairside Software, Dentsply Sirona (2020) Summary page 7.

## Indications for use
The Dentsply Sirona Titanium Bases system is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. For ATEV 3.0 S, ATTX 3.0 S, BH 3.0 S, and SB L 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. The system comprises three parts: » Abutment Block material (CEREC Cercon 4D Abutment Block) * Titanium Base (TiBase) * CAD/CAM system The TiBase is recommended for use with two-piece hybrid abutments and hybrid abutment crowns, used in conjunction with endosseous dental implants. Implant Systems: - Dentsply Sirona: AstraTech Implant EV, PrimeTaper EV, OmniTaper EV, Astra Tech OsseoSpeed TX, Ankylos - BioHorizons: Internal connection - Nobel Biocare: Replace, Replace Select, Nobel Active, NobelReplace Conical Connection, Branemark, NobelSpeedy Groovy - Osstem/Hiossen: Osstem TS, USA: Hiossen ET - Straumann: Bone Level, Tissue Level - Thommen Medical: Element, Contact - Zimmer/Biomet: Certain, External hex, Tapered Screw-Vent CAD/CAM Systems: - Sirona Dental CAD/CAM System Platforms: Manufacturer: Dentsply Sirona Implant: Astra Tech Implant EV, PrimeTaper EV, OmniTaper EV Platform: XS; TiBase AT EV 3.0 GH1 S; Reference: 6586304; Size S Platform: S; TiBase AT EV 3.6 GH1 S; Reference: 6586312; Size: S Platform: M; TiBase AT EV 4.2 GH1 L; Reference: 6586320; Size: L Platform: L; TiBase AT EV 4.8 GHI L; Reference: 6586338; Size: L Platform: XS; TiBase AT EV 3.0 GH2 S; Reference: 6832575; Size S Platform: S; TiBase AT EV 3.6 GH2 S; Reference: 6832583; Size: S Platform: M; TiBase AT EV 4.2 GH2 L; Reference: 6832591; Size: L Platform: L; TiBase AT EV 4.8 GH2 L; Reference: 6832609; Size: L Platform: XS; TiBase AT EV 3.0 GH3 S; Reference: 6832625; Size S Platform: S; TiBase AT EV 3.6 GH3 S; Reference: 6832633; Size: S Platform: M; TiBase AT EV 4.2 GH3 L; Reference: 6832641; Size: L Platform: L; TiBase AT EV 4.8 GH3 L; Reference: 6832658; Size: L Manufacturer: Dentsply Sirona Implant: Astra Tech Implant EV, OmniTaper EV Platform: XL; TiBase AT EV 5.4 GH1 L; Reference: 6586346; Size: L Platform: XL; TiBase AT EV 5.4 GH2 L; Reference: 6832617 Size: L Platform: XL; TiBase AT EV 5.4 GH3 L; Reference: 6832666; Size: L Manufacturer: Dentsply Sirona Implant: Astra Tech OsseoSpeed TX Platform 3.0; TiBase AT TX 3.0; Reference: 6598085 Size: S Platform 3.5/ 4.0; TiBase AT TX 3.5/4.0 L; Reference: 6598093; Size: L Platform 4.5/ 5.0; TiBase AT TX 4.5/5.0 L; Reference: 6598101; Size: L Manufacturer: Dentsply Sirona Implant: Ankylos Platform: C/X; TiBase ANK C/ GH 1 S; Reference: 6586528; Size: Platform: C/X; TiBase ANK C/ GH 2 S; Reference: 6586536; Size: Platform: C/X; TiBase ANK /X GH 1 S; Reference: 6586544; Size: Platform: C/X; TiBase ANK /X GH 2 S; Reference: 6586551; Size: Manufacturer: BioHorizons Implant: Internal Connection Platform: 3.0; TiBase BH 3.0 S; Reference: 6532779; Size: S Platform: 3.5; TiBase BH 3.5 L; Reference: 6532894; Size: L Platform: 4.5; TiBase BH 4.5 L; Reference: 6532951; Size: L Platform: 5.7; TiBase BH 5.7 L; Reference: 6536242; Size: L Manufacturer: Nobel Biocare Implant: Replace, Replace Select Platform: NP; TiBase NB RS 3.5 L; Reference: 6282474; Size: L Platform: RP; TiBase NB RS 4.3 L; Reference: 6282482; Size: L Platform: WP; TiBase NB RS 5.0 L; Reference: 6282490; Size: L Platform: 6.0; TiBase NB RS 6.0 L; Reference: 6282508; Size: L Manufacturer: Nobel Biocare Implant: Nobel Active, NobelReplace Conical Connection Platform: NP; TiBase NB A 4.5 L; Reference: 6308188; Size: L Platform: RP; TiBase NB A 5.0 L; Reference: 6308253; Size: L Manufacturer: Nobel Biocare Implant: Branemark, NobelSpeedy Groovy Platform: NP, TiBase NB B 3.4 L; Reference: 6282516; Size: L Platform: RP; TiBase NB B 4.1 L; Reference: 6282524; Size: L Manufacturer: Osstem / Hiossen Implant: Osstem TS (US Hiossen ET) Platform: Mini; TiBase O TS 3.5 L; Reference: 6527035; Size: L Platform: Regular; TiBase O TS 4.0 L; Reference: 6527043; Size: L Manufacturer: Straumann Implant: Bone Level Platform: NC (3.3 mm); TiBase S BL 3.3 L; Reference: 6308154; Size: L Platform: RC (4.1 mm /4.8 mm); TiBase S BL C 4.1 L; Reference: 6308337; Size: L Manufacturer: Straumann Implant: Tissue Level Platform: RN (4.8 mm); TiBase S SO 4.8 L; Reference: 6284249; Size: L Platform: WN (6.5 mm); TiBase S SO 6.5 L; Reference: 6284256, Size: L Manufacturer: Thommen Medical Implant: Element, Contact Platform: 3.5; TiBase TM 3.5 S; Reference: 6531854; Size: S Platform: 4; TiBase TM 4 S; Reference: 6532829; Size: S Platform: 4.5; TiBase TM 4.5 S; Reference: 6532837; Size: S Platform: 5; TiBase TM 5 S; Reference: 6544360; Size: S Platform: 6; TiBase TM 6 S; Reference: 6544378; Size: S Manufacturer: Zimmer / Biomet Implant: Certain Platform: 3.4; TiBase B C 3.4 S; Reference: 6308048; Size: S Platform: 4.1; TiBase B C 4.1 L; Reference: 6308097; Size: L Platform: 5.0; TiBase B C 5.0 L; Reference: 6308121; Size: L Manufacturer: Zimmer / Biomet Implant: External hex Platform: 3.4; TiBase B O 3.4 L; Reference: 6282557, Size: Platform: 4.1; TiBase B O 4.1 L; Reference: 6282565; Size: Platform: 5.0; TiBase B O 5.0 L; Reference: 6282573; Size: Manufacturer: Zimmer / Biomet Implant: Tapered Screw-Vent Platform: 3.5; TiBase Z TSV 3.5 L; Reference: 6282581; Size: L Platform: 4.5; TiBase Z TSV 4.5 L; Reference: 6282599; Size: L Platform: 5.7; TiBase Z TSV 5.7 L; Reference: 6282607; Size: L

Source page: https://510kreport.com/device/K250295
Methodology: https://510kreport.com/methodology