FDA Device Intelligence
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Unit, Operative Dental

FDA product code EIA · Class 1 · Dental

1,567
Registered devices
1,410
Adverse events
4
Recalls
285
510(k) clearances

Devices with this code

STRADIS — STRADIS MEDICAL, LLCAseptico — ASEPTICO, INC.STRADIS — STRADIS MEDICAL, LLCDCI — DCI International, LLCDCI Edge — DCI International, LLCSTRADIS — STRADIS MEDICAL, LLCSTRADIS — STRADIS MEDICAL, LLCDCI — DCI International, LLCDCI — DCI International, LLCDCI — DCI International, LLCAseptico — ASEPTICO, INC.STRADIS — STRADIS MEDICAL, LLCDentacenter Operative Dental Unit — Safari Dentaire IncAsst Arm - Top Mount — Engle Dental Systems, LLCSet Optima MX2 PRO INT — Bien-Air Dental SASTRADIS — STRADIS MEDICAL, LLCDCI — DCI International, LLCACTEON — SATELECDCI — DCI International, LLCForest — Ls Enterprises, Inc.Forest — Ls Enterprises, Inc.Evogue Dental Unit — TAKARA BELMONT CORP.STRADIS — STRADIS MEDICAL, LLCn/a — Ergonomic Products, Inc.

Recent recalls

DateFirmReason
2016-06-24Danville Materials, Inc.The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date. Danville Materials has become aware t
2014-04-23William C. Domb, D.M.D., A Professional CorporationWilliam Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use.
2013-11-05ASI Medical, Inc.ASI Medical is initiating a field correction for the SEAC Advanced Dental System because the miniature plastic air tank can potentially rupture.
2012-02-20Pelton & Crane CompanyModification of the Pelton & Crane Spirit 3000 unit disabled the TLC SAFEdrive feature rendering it ineffective in detecting whether the handpiece is potentiall

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.