# S.I.N. - Sistema DE Implante Nacional S.A.

- Location (FDA's records): São Paulo, BR
- FDA decisions: 18 (2005–2024): 18 510(k) clearances
- Names in FDA's records: S.I.N. - Sistema DE Implante Nacional S.A. (12); S.I.N. – Sistema DE Implante Nacional S.A. (5); Sin Sistema DE Implante Nacional Ltda (1)
- Product codes: DZE (12), KCT (5), NHA (1)
- 510(k) review time since 2016: median 135 days, against 222 for FDA's reviews in the same codes and years (13 of 17 faster)
- Predicates its devices cite: 52 (32 its own); citations of its devices by later devices: 44 (32 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nobel Biocare AB: 4 (https://510kreport.com/company/nobel-biocare)
- Jjgc Industria E Comercio DE Materiais Dentarios S.A.: 2 (https://510kreport.com/company/jjgc-industria-e-comercio-de-materiais-dentarios)
- Astra Tech, Inc.: 2 (https://510kreport.com/company/astra-tech)
- Bicon, Inc.: 2 (https://510kreport.com/company/bicon)
- Jjgc Industria E Comercio DE Materiais Dentarios S: 2 (https://510kreport.com/company/jjgc-industria-e-comercio-de-materiais-dentarios-s)
- Nobelpharma USA, Inc.: 2 (https://510kreport.com/company/nobelpharma-usa)
- Imtec Corp.: 1 (https://510kreport.com/company/imtec)
- Promimic AB: 1 (https://510kreport.com/company/promimic)

## Firms that cite its devices most
- S.I.N. Implant System Ltda: 7 (https://510kreport.com/company/sin-implant-system)
- Implacil DE Bortoli Material Odontologico Ltda: 2 (https://510kreport.com/company/implacil-de-bortoli-material-odontologico)
- D.S.P Industrial Eireli: 1 (https://510kreport.com/company/dsp-industrial-eireli)
- B.T.I. Biotechnology Institute, Sl.: 1 (https://510kreport.com/company/bti-biotechnology-institute)
- Medentis Medical GmbH: 1 (https://510kreport.com/company/medentis-medical)

## Its most-cited devices
- K170392: S.I.N. Implant System (2017), cited by 10
- K170398: S.I.N. Dental Implant System (2017), cited by 6
- K193096: S.I.N. Dental Implant System (2020), cited by 5
- K201688: S.I.N. Instrument Kits (2020), cited by 4
- K222231: S.I.N. Dental Implant System (2022), cited by 4
- K051859: Sistema DE Implante Nacional (S.I.N.); Dental Implant System (2005), cited by 3

## Recent decisions
- K240609: S.I.N. Dental Implant System (Jul 17, 2024)
- K241378: S.I.N. Instrument Kits (Jul 12, 2024)
- K232821: S.I.N. Dental Implant System (May 31, 2024)
- K231127: S.I.N. Dental Implant System (Dec 7, 2023)
- K230069: S.I.N. Dental Implant System (Apr 6, 2023)
- K221453: S.I.N. Dental Implant System (Dec 15, 2022)
- K222231: S.I.N. Dental Implant System (Oct 27, 2022)
- K222514: S.I.N. Instrument Kits (Oct 27, 2022)

Source page: https://510kreport.com/company/sin-sistema-de-implante-nacional