KometaBio Inc
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000013688 FEI 3013681878
- Devices
- 5
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
Catalogue
Dentin Graft Accelerator Kit Ref SK109B
CE MDR EUDAMEDSmart Grinder Single Use Chamber Ref GC106
CE MDR EUDAMEDSmart Dentin Grinder Ref GR101
CE MDR EUDAMEDDentin Cleansing Kit Ref SK108B
CE MDR EUDAMEDGrinding Chamber Ref GC106
CE MDR EUDAMED
Company details
- EUDAMED SRN
- US-MF-000013688
- FDA FEI number
- 3013681878
- EUDAMED status
- Active
- EUDAMED registered name
- KometaBio Inc
- EUDAMED abbreviated name
- KometaBio
- Registered address
- 1, One Bridge Plaza North, 07024, FORT LEE, NJ, United States
- Website
- www.kometabio.com
- facebook.com/KometaBio
- [email protected]
- Phone
- +18667722871
- PRRC contact
- Amit Binderman
From the company website
KometaBio developed the Smart Dentin Grinder which turns a patient's extracted tooth into autologous bone graft in 7 minutes chairside — predictable regeneration for every patient.
Frequently asked questions
How many devices does KometaBio Inc have in the registry?
The registry currently lists 5 devices for KometaBio Inc. Devices recorded under merged duplicate company entries are counted once.
Which registries list KometaBio Inc's devices?
Among its 5 most recently registered devices, KometaBio Inc has devices listed in EUDAMED (5 devices).
What risk classes do KometaBio Inc's devices fall under?
Among its 5 most recently registered devices, the classes recorded for KometaBio Inc's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from KometaBio Inc in the registry?
The most recently registered devices listed for KometaBio Inc include Dentin Graft Accelerator Kit, Smart Grinder Single Use Chamber, Smart Dentin Grinder and Dentin Cleansing Kit.