PROBE TIP/PERI PROBE/PERI PROBE COMP.
FDA 510(k) clearance K936221 · decided 1994-08-01
Clearance details
- K-number
- K936221
- Device name
- PROBE TIP/PERI PROBE/PERI PROBE COMP.
- Applicant
- Pd International AB
- Decision
- Substantially Equivalent
- Date received
- 1993-12-27
- Decision date
- 1994-08-01
- Days to decision
- 217 days
- Clearance type
- Traditional
- Product code
- EIX
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Sloane, SE
- 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 |
|---|---|---|
| VIP VICTOR INTERACTIVE PROBE (K960245) | Pro-Dentec | 1996-04-04 |
| THE VIVACARE T.P.S. PROBE (K944848) | Rms Div. | 1994-12-14 |
| ALBUMIN REAGENT (K890333) | Alpkem Corp. | 1989-02-17 |
| ACCUTEK PERIODONTAL PROBE (K880827) | Sweet Micro Systems, Inc. | 1988-04-12 |
| FLORIDA PROBE (K875076) | Florida Probe Corp. | 1988-03-10 |
| ACCUDENT ACCUPROBE (K870280) | Accudent, Inc. | 1987-06-08 |
| DISPOSABLE PERIODONTAL PROBE (K871504) | Periodontal Health Brush, Inc. | 1987-05-06 |
| DENTAL INSTRUMENTS - PROBES (K823324) | Miltex, Inc. | 1982-11-24 |
Recalls involving this device
No recalls on record reference this clearance.