SOFT PLATE CUSHION
FDA 510(k) clearance K813190 · decided 1982-02-05
Clearance details
- K-number
- K813190
- Device name
- SOFT PLATE CUSHION
- Applicant
- Leonard Russo Co.
- Decision
- Substantially Equivalent
- Date received
- 1981-11-16
- Decision date
- 1982-02-05
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- EHS
- Device class
- 2
- Regulation number
- 872.3540
- 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 |
|---|---|---|
| SMILE WITH CONFIDENCE (K971002) | Lloyd V. Ziemendorf | 1997-07-15 |
| CUSHIONS, DENTURE ADHESIVE, ALL-DAY (K770413) | Combe, Inc. | 1977-06-24 |
Recalls involving this device
No recalls on record reference this clearance.