AUSTENAL CONDENSING INSTRUMENT
FDA 510(k) clearance K865025 · decided 1987-02-19
Clearance details
- K-number
- K865025
- Device name
- AUSTENAL CONDENSING INSTRUMENT
- Applicant
- Austenal Dental, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-23
- Decision date
- 1987-02-19
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- EKG
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Chicago, 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 |
|---|---|---|
| ISOSTATIC CONDENSER (K843901) | Shofu Dental Corp. | 1984-12-03 |
| DENTAL INSTRUMENTS - PLUGGERS (K823322) | Miltex, Inc. | 1982-11-24 |
Recalls involving this device
No recalls on record reference this clearance.