# K193408: Sirona Dental CAD/CAM System with CEREC Chairside Software

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Aug 16, 2020 after 251 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). 121 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181520: Sirona Dental CAD/CAM System, Dentsply Sirona (2018) Summary page 6.

## Most influential descendants
- K250295: Dentsply Sirona Titanium Bases system (2025), 0 descendants of its own
- K233285: KATANA Zirconia ONE For IMPLANT (2024), 0 descendants of its own

## Indications for use
The Sirona Dental CAD/CAM System with CEREC Chairside Software is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the AT TX 3.0 S, BH 3.0 S, SSO 3.5 L, and SBL 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 consists of three major parts: TiBase, inCoris mesostructure and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two-piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.XXXX) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructure. The inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems: Nobel Biocare — Replace: NP, 3.5; RP, 4.3; WP, 5.0; 6.0, 6.0. Active: NP, 3.5; RP, 4.3/5.0. Branemark: NP, 3.3; RP, 3.75/4.0. Straumann — Synocta: NN (3.5mm), 3.3; RN (4.8mm), 3.3/4.1/4.8; WN (6.5mm), 4.8. Bone Level: NC (3.3mm), 3.3; RC (4.1mm/4.8mm), 4.1/4.8. Dentsply Sirona Implants — Osseospeed: 3.5/4.0, 3.5 S / 4.0 S; 4.5/5.0, 4.5/5.0/5.0 S. Xive: 3.4, 3.4; 3.8, 3.8; 4.5, 4.5; 5.5, 5.5. Osseospeed EV: 3.6, 3.6; 4.2, 4.2; 4.8, 4.8; 5.4, 5.4. Ankylos: C/X, A, B, C, D. Osseospeed TX: 3.0, 3.0; 3.5/4.0, 3.5/4.0; 4.5/5.0, 4.5/5.0. Biomet 3i — Osseotite: 3.4, 3.25 / 3.75; 4.1, 4.1 / 3/4; 5.0, 5.0 / 4/5. Certain: 3.4, 3.25 / 4/3 / 3/4/3; 4.1, 4.0 / 4/5/4 / 5/4; 5.0, 5.0 / 4/5. Zimmer — Tapered Screw-Vent: 3.5, 3.7/4.1; 4.5, 4.7; 5.7, 6. Thommen Medical — Thommen Medical Implants: 3.5, 3.5; 4, 4; 4.5, 4.5; 5, 5; 6, 6. Osstem / Hiossen — Osstem TS Implant System: Mini, 3.5. Hiossen Implant System: Regular, 4.0/4.5/5.0/6.0/7.0. BioHorizons (Internal Connection) — Tapered 3.0, Tapered plus: 3.0, 3.0/3.4/3.8; Tapered internal: 3.0, 3.0; Tapered plus: 4.6; Tapered internal, Tapered internal tissue level: 3.5, 3.0/3.8; Internal dental implant: 3.5; Single stage dental implants: 3.5/4.0; Tapered Plus: 5.8; Tapered internal, Tapered internal tissue level: 4.5, 4.6; Internal dental implant: 4.0; Single stage dental implants: 4.0/5.0; Tapered internal, Tapered internal tissue level: 5.7, 5.8; Internal dental implant, Single stage dental implants: 5.0/6.0.

Source page: https://510kreport.com/device/K193408
Methodology: https://510kreport.com/methodology