The following data is part of a premarket notification filed by Mrlb Intl., Inc. with the FDA for Dentapure Dental Unit Water Line Filter-iodinated.
| Device ID | K963548 |
| 510k Number | K963548 |
| Device Name: | DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED |
| Classification | Unit, Operative Dental |
| Applicant | MRLB INTL., INC. 305 DEMERS, P.O. BOX 4 East Grand Forks, MN 56721 |
| Contact | Rex A Hammarback |
| Correspondent | Rex A Hammarback MRLB INTL., INC. 305 DEMERS, P.O. BOX 4 East Grand Forks, MN 56721 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-05 |
| Decision Date | 1997-01-22 |
| Summary: | summary |