Collagen Corp.
United StatesFDA applicant, unverified
- Devices
- 10
What Collagen Corp. makes
Collagen Corp. manufactures dental surgical instruments and bone regeneration products, including handpieces, irrigation units, and precision dental attachments like the Osseodent system. Their portfolio also includes bioabsorbable grafting materials such as AlveoForm Biograft and Vitrogen TM 100, designed for bone augmentation and implant stabilization procedures.
The company’s devices are regulated under FDA pathways, with Class I and Class II classifications, and are authorised via 510(k) and PMA submissions. Products are listed in the U.S. under FDA regulatory frameworks.
Catalogue
Qar Handpiece Ref K904671
Regimes: 510(k) Registry: 510(k)Dental Hand Instruments Ref K883322
Regimes: 510(k) Registry: 510(k)Osseodent Surgical Kit Ref K894331
Regimes: 510(k) Registry: 510(k)Osseotite Irrigation Unit Ref K901600
Regimes: 510(k) Registry: 510(k)Osseodent Dental Attachment, Igloo Magnet Ref K900275
Regimes: 510(k) Registry: 510(k)Osseodent(R) Precision Dental Attachments Ref K895463
Regimes: 510(k) Registry: 510(k)Vitrogen Tm 100 Ref K812617
Regimes: 510(k) Registry: 510(k)Osseodent Dental Attachments Ref K895462
Regimes: 510(k) Registry: 510(k)Osseodent Dental Attachments (Non-Angled) Ref K904228
Regimes: 510(k) Registry: 510(k)Alveoform Tm Biograft Ref P860012
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Collagen Corp. have in the registry?
The registry currently lists 10 devices for Collagen Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Collagen Corp.'s devices?
Among its 10 most recently registered devices, Collagen Corp. has devices listed in FDA 510(k) (9 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Collagen Corp.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Collagen Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Collagen Corp. in the registry?
The most recently registered devices listed for Collagen Corp. include QAR HANDPIECE, DENTAL HAND INSTRUMENTS, OSSEODENT SURGICAL KIT and OSSEOTITE IRRIGATION UNIT.