Straumann Manufacturing, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 3033781108
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 20
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Modification To:straumann Guided Instruments Ref K090260
Regimes: 510(k) Registry: 510(k)Straumann Dental Abutments Ref K092814
Regimes: 510(k) Registry: 510(k)P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent Copings Ref K080239
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3033781108
- Address
- 60 Minuteman Road, Andover, MA, 01810
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 7
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 2 Oct 2018 Z-0455-2019 Class II Terminated Laser engraved label does not match with the item in the package
- 23 Mar 2018 Z-1693-2018 Class II Terminated A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
- 23 Mar 2018 Z-1694-2018 Class II Terminated A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
- 23 Mar 2018 Z-1695-2018 Class II Terminated A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
- 23 Mar 2018 Z-1696-2018 Class II Terminated A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
- 23 Mar 2018 Z-1697-2018 Class II Terminated A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
- 23 Mar 2018 Z-1698-2018 Class II Terminated A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
2016
- 23 Nov 2016 Z-0957-2017 Class II Terminated Drills cannot be inserted into handpiece due to tolerance specification not met
- 23 Nov 2016 Z-0958-2017 Class II Terminated Drills cannot be inserted into handpiece due to tolerance specification not met
- 14 Jul 2016 Z-2534-2016 Class II Terminated Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration
Show all 20 recalls
2016
- 14 Jul 2016 Z-2535-2016 Class II Terminated Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration
2011
- 4 Aug 2011 Z-3184-2011 Unclassified (pre-2012) Terminated Software version 8.0 has a software anomaly, in which the length is not adjusted accordingly when it is changed after the surgical sleeve position planning step has been completed.
2010
- 30 Sep 2010 Z-1592-2011 Unclassified (pre-2012) Terminated Software: Surgical Error may occur when the implant length is changed after positioning the surgical sleeve.
- 15 Jun 2010 Z-2177-2010 Unclassified (pre-2012) Terminated The label on the tubular packaging for the Straumann Impression set f. WN solid abutment has the incorrect description of RN solid abutment instead of a WN.
2009
- 4 Jun 2009 Z-0320-2011 Unclassified (pre-2012) Terminated Incorrect Inner diameter of the T-sleeve
2008
- 28 May 2008 Z-1876-2008 Unclassified (pre-2012) Terminated Handpiece driver is out of specification and will not function with the dental solid abutment. Possible risks involved include: inconvenience to patient and the need to reschedule surgery or proceed without the device.
2006
- 30 Mar 2006 Z-0840-06 Unclassified (pre-2012) Terminated The occlusal screw is inserted in the bottom of the healing cap body rather than correctly through the top
- 30 Jan 2006 Z-0602-06 Unclassified (pre-2012) Terminated Pilot drills may not fully extend through drill guide in template products
- 30 Jan 2006 Z-0603-06 Unclassified (pre-2012) Terminated Pilot drills may not fully extend through drill guide in template products
2005
- 6 Jun 2005 Z-0975-05 Unclassified (pre-2012) Terminated Basal screw is too short to adequately hold the dental abutment in the implant
Frequently asked questions
How many devices does Straumann Manufacturing, Inc. have in the registry?
The registry currently lists 4 devices for Straumann Manufacturing, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Straumann Manufacturing, Inc.'s devices?
Among its 4 most recently registered devices, Straumann Manufacturing, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Straumann Manufacturing, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Straumann Manufacturing, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Straumann Manufacturing, Inc.?
FDA recall records list 20 recalls initiated by Straumann Manufacturing, Inc., the most recent initiated on 2 Oct 2018. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Straumann Manufacturing, Inc. in the registry?
The most recently registered devices listed for Straumann Manufacturing, Inc. include MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS, STRAUMANN DENTAL ABUTMENTS, P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS and P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP).