Ormco Corporation
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000038085 FEI 3015272949
- Devices
- 6,701
- Registrations
- EUDAMEDFDA
- FDA recalls
- 11
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- Kerr Italia SRLIT
Catalogue
Search and filter all 6,701 devicesShowing 1-50 of 6,701
Company details
- EUDAMED SRN
- US-MF-000038085
- FDA FEI number
- 3015272949
- DUNS number
- 154614119
- EU VAT number
- 33-0463207
- EUDAMED status
- Active
- EUDAMED registered name
- Ormco Corporation
- Registered address
- 200, S Kraemer Blvd, 92821, Brea, United States
- Phone
- +18008541741
- PRRC contact
- Procoro Herrera
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 5 Mar 2029
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 769045 Active
Quality management system EU MDR
- Issued
- 6 Mar 2024
- Expires
- 5 Mar 2029
FDA recalls
2011
- 18 May 2011 Z-0200-2012 Unclassified (pre-2012) Terminated Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error.
Full distribution text
- 18 May 2011 Z-0201-2012 Unclassified (pre-2012) Terminated Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error.
Full distribution text
- 15 Mar 2011 Z-0639-2012 Unclassified (pre-2012) Terminated The TMA Lower Broad Arch packages labeled with part number 211-1402 actually contained TMA Upper Archwires, part number 2021007.
Full distribution text
- 18 May 2011 Z-0200-2012 Unclassified (pre-2012) Terminated Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error.
2010
- 9 Sep 2010 Z-0160-2012 Unclassified (pre-2012) Terminated The recall was initiated because SybronEndo has confirmed that the Microseal Master Cones has been mislabeled.
Full distribution text
- 9 Sep 2010 Z-0160-2012 Unclassified (pre-2012) Terminated The recall was initiated because SybronEndo has confirmed that the Microseal Master Cones has been mislabeled.
2009
- 2 Oct 2009 Z-1148-2012 Unclassified (pre-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.
- 13 Feb 2009 Z-1136-2012 Unclassified (pre-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.
Full distribution text
2008
- 1 Aug 2008 Z-1172-2012 Unclassified (pre-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.
Full distribution text
- 1 Aug 2008 Z-1172-2012 Unclassified (pre-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.
2007
- 31 Oct 2007 Z-0916-2008 Unclassified (pre-2012) Terminated Mislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of 2009/07.
2005
- 3 Nov 2005 Z-0203-06 Unclassified (pre-2012) Terminated Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.
- 3 Nov 2005 Z-0204-06 Unclassified (pre-2012) Terminated Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.
Show all 11 recalls
2004
- 18 Nov 2004 Z-0309-05 Unclassified (pre-2012) Terminated Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed.
Full distribution text
- 18 Nov 2004 Z-0309-05 Unclassified (pre-2012) Terminated Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed.
Frequently asked questions
How many devices does Ormco Corporation have in the registry?
The registry currently lists 6701 devices for Ormco Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ormco Corporation's devices?
Among its 50 most recently registered devices, Ormco Corporation has devices listed in EUDAMED (15 devices) and FDA GUDID (35 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Ormco Corporation's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Ormco Corporation's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Ormco Corporation?
FDA recall records list 11 recalls initiated by Ormco Corporation, the most recent initiated on 18 May 2011. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for Ormco Corporation?
EUDAMED lists 1 certificate for Ormco Corporation (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 6 Mar 2024.
What are the newest devices from Ormco Corporation in the registry?
The most recently registered devices listed for Ormco Corporation include ORMCO DIGITAL BONDING KIT - DAMON CLEAR (UPPER ARCH), ORMCO DIGITAL BONDING KIT - MINI-TWIN (DOUBLE ARCH), ORMCO DIGITAL BONDING KIT - TI-ORTHOS (DOUBLE ARCH) and ORMCO DIGITAL BONDING KIT - SYMETRI UPPER/ORTHOS LOWER (DOUBLE ARCH).