Ormco Corporation

11 FDA 510(k) clearances · Recalling firm

Record	Firm	Date
K3 Engine File G-Pack, Product: Endodontic Pulp Canal File, Part Number: 830-9925. For use recall (Z-1172-2012)	Ormco Corporation	2012-03-06
AdvanSync is an orthodontic device intended for the orthodontic treatment of Class II malo recall (Z-1148-2012)	Ormco Corporation	2012-03-05
Brand name: Orthos CM Bracket, Orthodontic Metal Bracket, Part Numbers: 454-1210, 454-0210 recall (Z-1136-2012)	Ormco Corporation	2012-03-01
TMA Archwires, Part Number 211-1402, Lot Number 10K291, Product Description and Intended U recall (Z-0639-2012)	Ormco Corporation	2012-01-11
Spirit MB Brackets, part #494-1210. The brand name of the device is Spirit MB Brackets, an recall (Z-0200-2012)	Ormco Corporation	2011-11-16
Spirit MB Brackets, part #494-1211. The brand name of the device is Spirit MB Brackets, an recall (Z-0201-2012)	Ormco Corporation	2011-11-16
Microseal Master Cone Part Number: 815-9033 Microseal Master Cone is intended to obturate recall (Z-0160-2012)	Ormco Corporation	2011-11-04
Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot recall (Z-0916-2008)	Ormco Corporation	2008-04-10
Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4210 Lot Number100512025 and recall (Z-0203-06)	Ormco Corporation	2005-11-26
Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4211 Lot Number 100514071 an recall (Z-0204-06)	Ormco Corporation	2005-11-26
Titanium Orthos Bracket recall (Z-0309-05)	Ormco Corporation	2004-12-15

Every clearance here is in the API, with alerts when new ones post.