DENTAL ORAL CARE SYSTEMS & COMPONENTS
FDA 510(k) clearance K844480 · decided 1985-06-19
Clearance details
- K-number
- K844480
- Device name
- DENTAL ORAL CARE SYSTEMS & COMPONENTS
- Applicant
- Advanced Bio Systems, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1984-11-19
- Decision date
- 1985-06-19
- Days to decision
- 212 days
- Clearance type
- Traditional
- Product code
- EBO
- Device class
- 2
- Regulation number
- 872.3570
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Valley Stream, NY, 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 |
|---|---|---|
| COMPLETE DENTURE REPAIR KIT (K850927) | Tooth Aid Lab, Inc. | 1985-07-02 |
| UNIVERSAL FIX-A-PLATE (K833057) | Laurentian Laboratories | 1984-02-27 |
| UNIVERSAL LINE-A-PLATE (K833056) | Laurentian Laboratories | 1984-02-27 |
| SAFE TDENT (K820245) | Professional Dental Studios | 1982-04-09 |
| DENTURE ADJUSTMENT KIT (K820685) | Camdent Laboratories | 1982-04-09 |
| EMERGENCY FAST-FIX DENTURE REPAIR KIT (K770091) | Mr. Clarence Hurst | 1977-01-24 |
Recalls involving this device
No recalls on record reference this clearance.