# Dentscare Ltda

- Location (FDA's records): Joinville, BR
- FDA decisions: 10 (2019–2024): 10 510(k) clearances
- Product codes: EBF (6), EBG (1), DYH (1), EMA (1), KLE (1)
- 510(k) review time since 2016: median 300 days, against 152 for FDA's reviews in the same codes and years (1 of 10 faster)
- Predicates its devices cite: 12 (2 its own); citations of its devices by later devices: 4 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ivoclar Vivadent, Inc.: 3 (https://510kreport.com/company/ivoclar-vivadent)
- Voco GmbH: 1 (https://510kreport.com/company/voco)
- Unitek Corp.: 1 (https://510kreport.com/company/unitek)
- Bisco, Inc.: 1 (https://510kreport.com/company/bisco)
- 3M Espe AG: 1 (https://510kreport.com/company/3m-espe)
- Ivoclar North America, Inc.: 1 (https://510kreport.com/company/ivoclar-north-america)
- 3M Company: 1 (https://510kreport.com/company/3m)
- 3M Espe Dental Products: 1 (https://510kreport.com/company/3m-espe-dental-products)

## Firms that cite its devices most
- Reliance Orthodontic Products, Inc.: 1 (https://510kreport.com/company/reliance-orthodontic-products)
- Prevest Denpro Limited: 1 (https://510kreport.com/company/prevest-denpro)

## Its most-cited devices
- K201707: Opallis, Opallis Flow (2020), cited by 2
- K192682: Orthocem, Ortho Bite (2020), cited by 1
- K191306: Llis, Vittra APS (2019), cited by 1

## Recent decisions
- K231859: PrimmaArt (Nov 26, 2024)
- K232994: Vittra APS Unique Flow (Oct 18, 2024)
- K210231: Vittra APS Unique (Oct 14, 2021)
- K201707: Opallis, Opallis Flow (Dec 22, 2020)
- K192682: Orthocem, Ortho Bite (Aug 14, 2020)
- K191389: Allcem Veneer APS (Feb 25, 2020)
- K191306: Llis, Vittra APS (Dec 16, 2019)
- K183424: Ambar, Ambar APS, Ambar Universal APS (Dec 13, 2019)

Source page: https://510kreport.com/company/dentscare