DENTAL D
FDA 510(k) clearance K974622 · decided 1998-02-10
Clearance details
- K-number
- K974622
- Device name
- DENTAL D
- Applicant
- Micro Dental Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1997-12-11
- Decision date
- 1998-02-10
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- EHP
- Device class
- 1
- Regulation number
- 872.3285
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Dublin, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Micro Dental Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ACETAL (K022032) | Inovativ, LLC | 2002-08-29 |
| ACETAL DENTAL/PREFORMED CLASP (K983558) | Dentamax, Inc. | 1999-01-07 |
| ACETAL DENTAL/PREFORMED CLASP (K954971) | B & H Technical Services , Ltd. | 1995-12-11 |
| ACETAL DENTAL/PREFORMED CLASP (K955946) | Pressing DI Monticelli Rag. Stefano | 1995-12-11 |
| INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH (K854765) | C&C Systems, Inc. | 1986-06-13 |
| VACUDENT LUMIX 70 (K800575) | Vacudent Sales Corp. | 1980-05-20 |
| VACUDENT LUMIX 65 (K800574) | Vacudent Sales Corp. | 1980-05-20 |
Recalls involving this device
No recalls on record reference this clearance.