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 |