The following data is part of a premarket notification filed by Micro Dental Laboratories with the FDA for Fusicryl.
| Device ID | K984467 | 
| 510k Number | K984467 | 
| Device Name: | FUSICRYL | 
| Classification | Resin, Denture, Relining, Repairing, Rebasing | 
| Applicant | MICRO DENTAL LABORATORIES 6665 AMADOR PLAZA RD., #200 Dublin, CA 94568 | 
| Contact | Nicolas E Azar | 
| Correspondent | Nicolas E Azar MICRO DENTAL LABORATORIES 6665 AMADOR PLAZA RD., #200 Dublin, CA 94568 | 
| Product Code | EBI | 
| CFR Regulation Number | 872.3760 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1998-12-16 | 
| Decision Date | 1999-02-24 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  FUSICRYL  75471627  2511353 Dead/Cancelled | 4T Quattroti S.r.L. 1998-04-21 |