The following data is part of a premarket notification filed by Almore Intl., Inc. with the FDA for Microfil Contouring Instruments.
| Device ID | K830776 | 
| 510k Number | K830776 | 
| Device Name: | MICROFIL CONTOURING INSTRUMENTS | 
| Classification | Instrument, Filling, Plastic, Dental | 
| Applicant | ALMORE INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | EIY | 
| CFR Regulation Number | 872.4565 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1983-03-11 | 
| Decision Date | 1983-04-28 |