The following data is part of a premarket notification filed by Interpore Intl. with the FDA for Tooth Root Socket Gauge.
Device ID | K843154 |
510k Number | K843154 |
Device Name: | TOOTH ROOT SOCKET GAUGE |
Classification | Bone Grafting Material, Synthetic |
Applicant | INTERPORE INTL. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LYC |
CFR Regulation Number | 872.3930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-10 |
Decision Date | 1984-10-01 |