The following data is part of a premarket notification filed by Mrlb Intl., Inc. with the FDA for Dentapure Dp 90 Cartridge, Dentapure Dp 365 Cartridge.
| Device ID | K992893 |
| 510k Number | K992893 |
| Device Name: | DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE |
| Classification | Unit, Operative Dental |
| Applicant | MRLB INTL., INC. 2450 COLLEGE WAY Fergus Falls, MN 56537 |
| Contact | B.j. Hammarback |
| Correspondent | B.j. Hammarback MRLB INTL., INC. 2450 COLLEGE WAY Fergus Falls, MN 56537 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-27 |
| Decision Date | 1999-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10732224005512 | K992893 | 000 |
| 10732224005680 | K992893 | 000 |
| 00732224005676 | K992893 | 000 |
| 00732224005683 | K992893 | 000 |
| D711DPI365B0 | K992893 | 000 |
| D711DPI365M08 | K992893 | 000 |
| D711DP365B0 | K992893 | 000 |
| D711DP365M08 | K992893 | 000 |
| 10732224005505 | K992893 | 000 |
| 10732224005673 | K992893 | 000 |