PIO ROOT CANAL INDICATOR
FDA 510(k) clearance K822793 · decided 1982-10-22
Clearance details
- K-number
- K822793
- Device name
- PIO ROOT CANAL INDICATOR
- Applicant
- National Patent Development Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-09-16
- Decision date
- 1982-10-22
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- EIL
- Device class
- 1
- Regulation number
- 872.4565
- 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 |
|---|---|---|
| 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 |
| PERIO-TEST (K872215) | Dr. Bernard Loewenthal | 1987-07-10 |
Recalls involving this device
No recalls on record reference this clearance.