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Sign in to claim this brandOrmco Corporation
United States·US-MF-000038085
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 200, S Kraemer Blvd, Brea, United States
- Website
- envistaco.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Procoro Herrera
- EUDAMED SRN
- US-MF-000038085
- FDA FEI Number
- 3015272949
- DUNS Number
- —
Catalogue (6676)
Page 1 of 134| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ormco | 422-0102 | FDA UDI | Class I | Active |
| Inspire ICE | 443-3711 | FDA UDI | Class II | Unknown |
| Ormco | 422-0001 | FDA UDI | Class I | Active |
| SpiritMB | 494-0725 | FDA UDI | Class II | Unknown |
| Inspire ICE | 443-3511 | FDA UDI | Class II | Unknown |
| Pulp Canal Sealer EWT | 24745 | FDA UDI | Class II | Active |
| Inspire ICE | 444-2011 | FDA UDI | Class II | Active |
| Ormco | 203-0007 | FDA UDI | Class I | Active |
| Ormco | 421-0008 | FDA UDI | Class I | Active |
| Facebow | 617-1008 | FDA UDI | Class II | Active |
| Inspire ICE | 444-1510 | FDA UDI | Class I | Active |
| SpiritMB | 494-0300 | FDA UDI | Class II | Unknown |
| Inspire ICE | 443-2210 | FDA UDI | Class II | Unknown |
| Ormco | 421-0003 | FDA UDI | Class I | Active |
| Insignia | 728-0114 | FDA UDI | Class I | Active |
| Insignia | 728-0503 | FDA UDI | Class I | Active |
| Insignia | 728-1306 | FDA UDI | Class I | Active |
| Elements | 973-0320 | FDA UDI | Class II | Active |
| Ormco | 225-0001 | FDA UDI | Class I | Active |
| Grounding Lead With Lip Clip | 973-0226 | FDA UDI | Class II | Active |
| Nexus Clear Roth | 436-3210 | FDA UDI | Class II | Unknown |
| Inspire ICE | 443-1310 | FDA UDI | Class I | Unknown |
| Insignia | 728-1405 | FDA UDI | Class I | Active |
| Insignia | 728-1511 | FDA UDI | Class I | Active |
| Inspire ICE | 443-3311 | FDA UDI | Class II | Unknown |
| Insignia | 728-0123 | FDA UDI | Class I | Active |
| Tubli-Seal Xpress | 33640 | FDA UDI | Class II | Active |
| Inspire ICE | 443-3610 | FDA UDI | Class II | Unknown |
| Insignia | 728-1200 | FDA UDI | Class I | Active |
| Tubli-Seal | 01081 | FDA UDI | Class II | Active |
| SpiritMB | 494-0411 | FDA UDI | Class II | Unknown |
| Damon 3 | 491-4721 | FDA UDI | Class II | Active |
| Mini-Tip Kit | 973-0231 | FDA UDI | Class II | Active |
| Insignia | 728-1202 | FDA UDI | Class I | Active |
| SpiritMB | 494-0301 | FDA UDI | Class II | Unknown |
| Inspire ICE | 443-0240 | FDA UDI | Class I | Active |
| Facebow | 617-1010 | FDA UDI | Class II | Active |
| Insignia | 728-0401 | FDA UDI | Class I | Active |
| Insignia | 728-1307 | FDA UDI | Class I | Active |
| Damon 3 | 491-5620 | FDA UDI | Class II | Active |
| Ormco | 422-0101 | FDA UDI | Class I | Active |
| Inspire ICE | 443-3310 | FDA UDI | Class II | Unknown |
| Damon 3 | 491-4140 | FDA UDI | Class II | Active |
| Inspire ICE | 443-0710 | FDA UDI | Class I | Unknown |
| Heat Carrier | 973-0217 | FDA UDI | Class II | Active |
| Insignia | 728-0402 | FDA UDI | Class I | Active |
| Ormco | 800-8013 | FDA UDI | Class I | Active |
| Insignia | 728-0510 | FDA UDI | Class I | Active |
| System 1+ | 740-0105 | FDA UDI | Class II | Unknown |
| Insignia | 728-0403 | FDA UDI | Class I | Active |
Related Companies
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Importers
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Authorities
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FDA Recalls (11)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 18, 2011 | Z-0201-2012 | — | terminated | Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error. |
| May 18, 2011 | Z-0200-2012 | — | terminated | Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error. |
| Mar 15, 2011 | Z-0639-2012 | — | terminated | The TMA Lower Broad Arch packages labeled with part number 211-1402 actually contained TMA Upper Archwires, part number 2021007. |
| Sep 9, 2010 | Z-0160-2012 | — | terminated | The recall was initiated because SybronEndo has confirmed that the Microseal Master Cones has been mislabeled. |
| Oct 2, 2009 | Z-1148-2012 | — | terminated | Manufacturing Error: There is a potential for a braze joint failure in the upper telescopic rod assembly. Although an incident could occur in which the eyelet loses connection from the rod, there is no risk of swallowing or aspirating the appliance because it will still be attached to the patient's crown. |
| Feb 13, 2009 | Z-1136-2012 | — | terminated | The recall was initiated because Ormco has confirmed that manufacturing error resulted in the Orthos CM Brackets being incorrectly manufactured with a torque of -9. The packaging was labeled with +9 torque; however the brackets contained inside the packaging are actually Orthos CM Brackets with a torque of -9. |
| Aug 1, 2008 | Z-1172-2012 | — | terminated | A recall was initiated because SybronEndo has confirmed that the K3 Engine File G-Pack has label packaging and file mis-marking error. |
| Oct 31, 2007 | Z-0916-2008 | — | terminated | Mislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of 2009/07. |
| Nov 3, 2005 | Z-0204-06 | — | terminated | Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance. |
| Nov 3, 2005 | Z-0203-06 | — | terminated | Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance. |
| Nov 18, 2004 | Z-0309-05 | — | terminated | Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed. |