# Harvest Dental Products, LLC

- Location (FDA's records): Brea, CA
- FDA decisions: 5 (2014–2023): 5 510(k) clearances
- Product codes: EBI (2), EBG (2), EIH (1)
- 510(k) review time since 2016: median 258 days, against 105 for FDA's reviews in the same codes and years (0 of 4 faster)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 2 (0 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
- GC America, Inc.: 1 (https://510kreport.com/company/gc-america)
- Union Dental S.A.: 1 (https://510kreport.com/company/union-dental)
- Dmax Co., Ltd.: 1 (https://510kreport.com/company/dmax)
- Vertex-Dental B.V.: 1 (https://510kreport.com/company/vertex-dental)
- Envisiontec GmbH: 1 (https://510kreport.com/company/envisiontec)

## Firms that cite its devices most
- New Stetic: 1 (https://510kreport.com/company/new-stetic)
- Ivoclar Vivadent, Inc.: 1 (https://510kreport.com/company/ivoclar-vivadent)

## Its most-cited devices
- K180578: Harvest Dental Polymer Blocks (2018), cited by 1
- K132937: Harvest Dental Polymer Blocks (Zcad, Aurora) (2014), cited by 1

## Recent decisions
- K231389: Harvest Dental HD Gum Strip (Aug 16, 2023)
- K222961: Harvest Conceal ZR Block Out (Jun 2, 2023)
- K222489: Harvest Printable Resin (May 12, 2023)
- K180578: Harvest Dental Polymer Blocks (Dec 12, 2018)
- K132937: Harvest Dental Polymer Blocks (Zcad, Aurora) (May 21, 2014)

Source page: https://510kreport.com/company/harvest-dental-products