RELINE-IT MODEL RELINE-IT
FDA 510(k) clearance K101771 · decided 2010-09-20
Clearance details
- K-number
- K101771
- Device name
- RELINE-IT MODEL RELINE-IT
- Applicant
- Majestic Drug Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-06-24
- Decision date
- 2010-09-20
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- EBP
- Device class
- 2
- Regulation number
- 872.3560
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Orange, CT, 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 |
|---|---|---|
| PROSOFT (K121318) | Perma Laboratories | 2012-06-06 |
| DENTURE-TIGHT (K790589) | Den-Mat Corp. | 1979-08-10 |
Recalls involving this device
No recalls on record reference this clearance.