The following data is part of a premarket notification filed by King Dental Corp. with the FDA for King-hue, Royal Coral, Super-c Artificial Teeth.
Device ID | K931162 |
510k Number | K931162 |
Device Name: | KING-HUE, ROYAL CORAL, SUPER-C ARTIFICIAL TEETH |
Classification | Denture, Plastic, Teeth |
Applicant | KING DENTAL CORP. 10544 N.W. 26TH STREET, SUITE 203 Miami, FL 33172 |
Contact | Jim Briggs |
Correspondent | Jim Briggs KING DENTAL CORP. 10544 N.W. 26TH STREET, SUITE 203 Miami, FL 33172 |
Product Code | ELM |
CFR Regulation Number | 872.3590 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-08 |
Decision Date | 1993-05-27 |