FLEXIDENT DENTURE
FDA 510(k) clearance K760768 · decided 1976-10-15
Clearance details
- K-number
- K760768
- Device name
- FLEXIDENT DENTURE
- Applicant
- Flexodent Corp.
- Decision
- Substantially Equivalent
- Date received
- 1976-10-04
- Decision date
- 1976-10-15
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- EKO
- Device class
- 2
- Regulation number
- 872.3600
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, 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 |
|---|---|---|
| DENE BRIDGE (K903672) | Dirotian Pty. , Ltd. | 1990-12-05 |
| DENTAL ROOT ELEVATOR (K892255) | Zinnanti Surgical Instruments, Inc. | 1989-05-01 |
| ADVANCED DENTURE SYSTEM (K780722) | Advanced Marketing Research Co. | 1978-05-26 |
Recalls involving this device
No recalls on record reference this clearance.