PROSOFT
FDA 510(k) clearance K121318 · decided 2012-06-06
Clearance details
- K-number
- K121318
- Device name
- PROSOFT
- Applicant
- Perma Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2012-05-02
- Decision date
- 2012-06-06
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- EBP
- Device class
- 2
- Regulation number
- 872.3560
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Hinckley, OH, US
- Third-party review
- Yes
- 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 |
|---|---|---|
| RELINE-IT MODEL RELINE-IT (K101771) | Majestic Drug Co., Inc. | 2010-09-20 |
| DENTURE-TIGHT (K790589) | Den-Mat Corp. | 1979-08-10 |
Recalls involving this device
No recalls on record reference this clearance.