The following data is part of a premarket notification filed by Harald Nordin Sa with the FDA for Dental Screw Posts.
Device ID | K931396 |
510k Number | K931396 |
Device Name: | DENTAL SCREW POSTS |
Classification | Post, Root Canal |
Applicant | HARALD NORDIN SA RESIDENCE TAMARIS FONTANIVENT-CH-1817 BRENT Montreux, Switzerland, CH |
Contact | Harald Nordin |
Correspondent | Harald Nordin HARALD NORDIN SA RESIDENCE TAMARIS FONTANIVENT-CH-1817 BRENT Montreux, Switzerland, CH |
Product Code | ELR |
CFR Regulation Number | 872.3810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-19 |
Decision Date | 1994-04-28 |