INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH
FDA 510(k) clearance K854765 · decided 1986-06-13
Clearance details
- K-number
- K854765
- Device name
- INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH
- Applicant
- C&C Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-11-27
- Decision date
- 1986-06-13
- Days to decision
- 198 days
- Clearance type
- Traditional
- Product code
- EHP
- Device class
- 1
- Regulation number
- 872.3285
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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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 |
| DENTAL D (K974622) | Micro Dental Laboratories | 1998-02-10 |
| 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 |
| 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.