Company · US
Ormco Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2025. Name variants (Inc, Corp, punctuation) are merged.
46510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DYW | Bracket, Plastic, Orthodontic | 13 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 11 |
| EJF | Bracket, Metal, Orthodontic | 10 |
| DZB | Headgear, Extraoral, Orthodontic | 4 |
| NJM | Bracket, Ceramic, Orthodontic | 3 |
| NXC | Aligner, Sequential | 3 |
| DZC | Wire, Orthodontic | 2 |
| EKS | File, Pulp Canal, Endodontic | 2 |
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 2 |
| DYJ | Retainer, Screw Expansion, Orthodontic | 1 |
| DZE | Implant, Endosseous, Root-Form | 1 |
| ECO | Spring, Orthodontic | 1 |
| ECR | Setter, Band, Orthodontic | 1 |
| EJT | Alloy, Gold-Based Noble Metal | 1 |
| EKM | Gutta-Percha | 1 |
| MDL | Implant, Transmandibular | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 20, 2025 | K250487 | SparkTM Clear Aligner System Ormco Corporation | NXC |
| Jan 3, 2025 | K250015 | Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive Ormco Corporation | DYH |
| Oct 11, 2024 | K240501 | Spark Clear Aligner System Ormco Corporation | NXC |
| Mar 22, 2021 | K203737 | Spark Clear Aligner System Ormco Corporation | NXC |
| Jan 31, 2018 | K172845 | Symetri Clear Ormco Corporation | NJM |
| Jul 18, 2017 | K171844 | Inspire ICE aka Inspire ICE Clear Brackets Ormco Corporation | NJM |
| Dec 5, 2014 | K141611 | LYTHOS DIGITAL IMPRESSION SYSTEM Ormco Corp. | NOF |
| Mar 26, 2013 | K123118 | INSIGNIA DIGICAST Ormco Corp. | DYW |
| Mar 13, 2013 | K123416 | INSIGNIA WITH ITERO Ormco Corp. | DYW |
| Feb 8, 2013 | K122065 | DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE Ormco Corp. | NOF |
| Aug 9, 2012 | K121524 | INSIGNIA Ormco Corp. | DYW |
| Nov 16, 2011 | K112640 | HYPERELASTIC WIRE Ormco Corp. | DZC |
| Sep 13, 2010 | K101676 | CLEARARCH Ormco Corp. | DYW |
| Oct 24, 2008 | K081900 | TEMPORARY TOOTH REPLACEMENT Ormco Corp. | DZE |
| Sep 24, 2008 | K081415 | DAMON 4CLEAR Ormco Corp. | NJM |
| Dec 13, 2006 | K062856 | TF ROTARY NICKEL TITANIUM FILE Ormco Corp. | EKS |
| Jul 6, 2006 | K061481 | GRENGLOO Ormco Corp. | DYH |
| Nov 30, 2005 | K052477 | DAMON 3 MODIFIED Ormco Corp. | DYW |
| Jan 4, 1996 | K955333 | SPIRIT MB Ormco Corp. | DYW |
| Jul 19, 1995 | K951239 | GLOWING SPIRITS Ormco Corp. | DYW |
| May 23, 1995 | K951776 | BAND SEATER Ormco Corp. | ECR |
| Jan 27, 1995 | K946255 | THERMASET Ormco Corp. | DYH |
| Aug 17, 1994 | K943068 | MAGNEFORCE Ormco Corp. | ECO |
| Mar 31, 1994 | K941015 | ORMCO SYSTEM 1+ (TM) Ormco Corp. | DYH |
| Oct 20, 1993 | K922806 | ORMCO SPORTSGUARD Ormco Corp. | EJF |
| May 5, 1993 | K923405 | THE HERBST APPLIANCE Ormco Corp. | EJF |
| Dec 4, 1992 | K923556 | ADP FACEMASK Ormco Corp. | DZB |
| Oct 27, 1992 | K923399 | CHALLENGE II - PASTE ADHESIVE Ormco Corp. | DYH |
| May 5, 1992 | K921245 | THE BRACKET ASSEMBLY W/ SECURITY SYSTEM II Ormco Corp. | DYH |
| Apr 21, 1992 | K921385 | IMPROVED SEQUENCE LIGHT CURE ADHESIVE Ormco Corp. | DYH |
| Jan 17, 1992 | K914727 | SEQUENCE LIGHT CURE ADHESIVE Ormco Corp. | DYH |
| Nov 20, 1991 | K914616 | KLEER(TM) ORTHODONTIC BRACKET Ormco Corp. | EJF |
| Dec 27, 1990 | K905197 | THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM Ormco Corp. | EJT |
| Sep 6, 1990 | K902646 | HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP Ormco Corp. | DZB |
| Sep 6, 1990 | K902645 | HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL Ormco Corp. | DZB |
| Apr 2, 1990 | K900184 | LINGUAL SHEATH Ormco Corp. | EJF |
| Mar 8, 1990 | K896913 | SPIRIT Ormco Corp. | DYW |
| Sep 15, 1989 | K894781 | OPTIFLEX Ormco Corp. | EJF |
| Sep 15, 1989 | K894358 | LUMINA ORTHODONTIC BRACKET Ormco Corp. | EJF |
| Jun 12, 1989 | K892704 | GEM II ORTHODONTIC BRACKET Ormco Corp. | EJF |
| Apr 25, 1989 | K890740 | FRS LITE FLUORIDE RELEASING SEALANT Ormco Corp. | DYH |
| Feb 19, 1987 | K870536 | GEM ORTHODONTIC BRACKET Ormco Corp. | EJF |
| Jan 21, 1987 | K863709 | CHALLENGE ORTHODONTIC BONDING ADHESIVE Ormco Corp. | DYH |
| Jul 11, 1986 | K862538 | SENTRY BREAKWAY NECK STRAP Ormco Corp. | DZB |
| Aug 29, 1985 | K852894 | ORMCO TRANSMANDIBULAR IMPLANT Ormco Corp. | MDL |
| Mar 15, 1978 | K780239 | BRACKET, METAL REINFORCED PLASTIC Ormco Corp. | DYW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2012 | Ormco Corporation K3 Engine File G-Pack,
Product: Endodontic Pulp Canal File, Part Number: 830-9925.
For use in root canal preparation. Terminated |
EKS | None listed |
| Mar 5, 2012 | Ormco Corporation AdvanSync is an orthodontic device intended for the orthodontic treatment of Class II malocclusions. The AdvanSync part numbers and lot numbers affected by this recall are as follows:
Part Number: Terminated |
DYJ | None listed |
| Mar 1, 2012 | Ormco Corporation Brand name: Orthos CM Bracket, Orthodontic Metal Bracket,
Part Numbers: 454-1210, 454-0210.
The intended use of this device is a fixed attachment on a tooth which holds an archwire during orthodontic Terminated |
EJF | None listed |
| Jan 11, 2012 | Ormco Corporation TMA Archwires, Part Number 211-1402, Lot Number 10K291, Product Description and Intended Use: The intended use of this device is an archwire during orthodontic treatment. Terminated |
DZC | None listed |
| Nov 16, 2011 | Ormco Corporation Spirit MB Brackets, part #494-1211.
The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit MB Brackets have been assigned the product code 76 DYW (Plastic Orthodontic Brac Terminated |
DYW | K943245 |
| Nov 16, 2011 | Ormco Corporation Spirit MB Brackets, part #494-1210.
The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit MB Brackets have been assigned the product code 76 DYW (Plastic Orthodontic Brac Terminated |
DYW | K943245 |
| Nov 4, 2011 | Ormco Corporation Microseal Master Cone Part Number: 815-9033
Microseal Master Cone is intended to obturate root canals during endodontic therapy procedures. Terminated |
EKM | None listed |
| Apr 10, 2008 | Ormco Corporation Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot Number 2792584, Ormco Corporation, Glendora, CA 91740 Terminated |
DYH | K061481 |
| Nov 26, 2005 | Ormco Corporation Damon 3 Bracket
Upper Right lateral .022 slot
Part Number 491-4211
Lot Number 100514071 and 100512012 Terminated |
DYW | K052477 |
| Nov 26, 2005 | Ormco Corporation Damon 3 Bracket
Upper Right lateral .022 slot
Part Number 491-4210
Lot Number100512025 and 100512020 Terminated |
DYW | K052477 |
| Dec 15, 2004 | Ormco Corporation Titanium Orthos Bracket Terminated |
EJF | None listed |