# A-Dec, Inc.

- Location (FDA's records): Newberg, OR
- FDA decisions: 69 (1989–2022): 69 510(k) clearances
- Product codes: EIA (25), EFB (19), KLC (18), EBW (2), ELC (1), ECB (1), FLE (1), EAZ (1), EBR (1)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 44 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Sirona Dental Systems GmbH: 3 (https://510kreport.com/company/sirona-dental-systems)
- Kaltenbach & Voigt GmbH: 3 (https://510kreport.com/company/kaltenbach-voigt)
- W&H Dentalwerk Buermoos GmbH: 3 (https://510kreport.com/company/w-h-dentalwerk-buermoos)
- J. Morita USA, Inc.: 3 (https://510kreport.com/company/j-morita-usa)
- Anodia Systems: 3 (https://510kreport.com/company/anodia-systems)
- Ergonomic Products, Inc.: 2 (https://510kreport.com/company/ergonomic-products)
- Nakanishi, Inc.: 2 (https://510kreport.com/company/nakanishi)
- W&H Dentalwerk Bürmoos GmbH: 2 (https://510kreport.com/company/w-h-dentalwerk-burmoos)

## Its most-cited devices
- K070663: A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97,  a-Dec/W&H Synea Handpiece Attachment (2007), cited by 7
- K102234: A-Dec 200 Dental System (2010), cited by 4
- K082827: A-Dec/W&H Profin Reciprocating Contra-Angle Handpiece Attachment (2009), cited by 4
- K993526: Synea - LS Low-Speed Handpiece (2000), cited by 4
- K962665: A-Dec Self-Contained Water System (1996), cited by 3
- K010127: W & H Assistina (2001), cited by 3

## Recent decisions
- K213932: A-dec 300, A-dec 500 (Mar 2, 2022)
- K133776: A-Dec/W&H Electric Handpiece Motor (May 28, 2014)
- K102234: A-Dec 200 Dental System (Nov 24, 2010)
- K100647: A-Dec/W&H Synea Sonic Scaler Handpiece, Models ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM (Jul 9, 2010)
- K082716: A-Dec/W&H Alegra Air-Driven Highspeed Handpiece, Model TE-97, TE-98, a-Dec/W&H Alegra Handpiece Attachment, Model HE-43 (Jan 15, 2009)
- K082827: A-Dec/W&H Profin Reciprocating Contra-Angle Handpiece Attachment (Jan 7, 2009)
- K082985: A-Dec 334/335 Delivery System (Dec 17, 2008)
- K070663: A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97,  a-Dec/W&H Synea Handpiece Attachment (Jul 5, 2007)

Source page: https://510kreport.com/company/a-dec
