OJ-1 ENDODONIC ROOT CANAL FILE HOLDER
FDA 510(k) clearance K801463 · decided 1980-07-21
Clearance details
- K-number
- K801463
- Device name
- OJ-1 ENDODONIC ROOT CANAL FILE HOLDER
- Applicant
- Almore Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-06-24
- Decision date
- 1980-07-21
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- EKQ
- 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 |
|---|---|---|
| VIBRATORY ENDODONTIC SYSTEM (K832378) | Syntex Dental Products, Inc. | 1983-10-04 |
Recalls involving this device
No recalls on record reference this clearance.