The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Miniendo Iii.
| Device ID | K003640 |
| 510k Number | K003640 |
| Device Name: | MINIENDO III |
| Classification | Scaler, Rotary |
| Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Contact | Colleen Bosell |
| Correspondent | Colleen Bosell SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Product Code | ELB |
| CFR Regulation Number | 872.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-27 |
| Decision Date | 2001-02-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613353169275 | K003640 | 000 |
| 07613353002619 | K003640 | 000 |
| 07613353002602 | K003640 | 000 |
| 07613353001766 | K003640 | 000 |