PERIO-TEST
FDA 510(k) clearance K872215 · decided 1987-07-10
Clearance details
- K-number
- K872215
- Device name
- PERIO-TEST
- Applicant
- Dr. Bernard Loewenthal
- Decision
- Substantially Equivalent
- Date received
- 1987-06-09
- Decision date
- 1987-07-10
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- EIL
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Portsmouth, NH, 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 |
|---|---|---|
| ABIODENT PERIOTEMP(R) SYSTEM (K911643) | Abiomed, Inc. | 1991-07-09 |
| FLORIDA PROBE PERIODONTAL PROBE (K890493) | Florida Probe Corp. | 1989-03-13 |
| ABIOMED PERIOTEMP(TM) PROBE (K885075) | Abiomed, Inc. | 1989-02-13 |
| MODEL 200A ELECTRONIC FORCE-SENSING PROBE (K884813) | Vine Valley Research | 1989-01-05 |
| PERIODONTAL PROBE - AUTOPROBE (K880209) | Dentsply Intl. | 1988-04-27 |
| CREMEEN ALVEOLAR BONE CALIPER (K872098) | Bowen & Company, Inc. | 1987-07-31 |
| PIO ROOT CANAL INDICATOR (K822793) | National Patent Development Corp. | 1982-10-22 |
Recalls involving this device
No recalls on record reference this clearance.