The following data is part of a premarket notification filed by Glustitch, Inc. with the FDA for Periacryl 90,80,70,60, Model9010, 8020, 7030, 6040.
| Device ID | K071484 |
| 510k Number | K071484 |
| Device Name: | PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040 |
| Classification | Cement, Dental |
| Applicant | GLUSTITCH, INC. #307 7188 PROGRESS WAY Delta, B.c., CA V4g 1m6 |
| Contact | Don Blacklock |
| Correspondent | Don Blacklock GLUSTITCH, INC. #307 7188 PROGRESS WAY Delta, B.c., CA V4g 1m6 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-30 |
| Decision Date | 2007-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D795101 | K071484 | 000 |
| D7950000041 | K071484 | 000 |
| D7950000050 | K071484 | 000 |
| D795013 | K071484 | 000 |
| D795023 | K071484 | 000 |
| D795033 | K071484 | 000 |
| D795041 | K071484 | 000 |
| D795051 | K071484 | 000 |
| D795071 | K071484 | 000 |
| D795081 | K071484 | 000 |
| D795091 | K071484 | 000 |
| D7950000021 | K071484 | 000 |