The following data is part of a premarket notification filed by Datum Dental Ltd with the FDA for Ossix Bone.
Device ID | K163714 |
510k Number | K163714 |
Device Name: | OSSIX BONE |
Classification | Bone Grafting Material, Animal Source |
Applicant | Datum Dental Ltd 1 Bat Sheva St., PO Box 6170 Lod, IL 7116003 |
Contact | Arie Goldlust |
Correspondent | Janice M Hogan HOGAN LOVELLS US LLP 1835 MARKET ST, 29TH FL Philadelphia, PA 19103 |
Product Code | NPM |
CFR Regulation Number | 872.3930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-12-30 |
Decision Date | 2017-07-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07290015477253 | K163714 | 000 |
07290015477222 | K163714 | 000 |
07290015477215 | K163714 | 000 |