PACIFIC IMPLANT TITANIUM ENDODONTIC POINT
FDA 510(k) clearance K992582 · decided 1999-10-21
Clearance details
- K-number
- K992582
- Device name
- PACIFIC IMPLANT TITANIUM ENDODONTIC POINT
- Applicant
- Pacific Implant, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-08-02
- Decision date
- 1999-10-21
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- EKL
- Device class
- 1
- Regulation number
- 872.3840
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Washington, DC, 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 |
|---|---|---|
| PULPDENT ENDOPREP II (K961089) | Pulpdent Corp. | 1996-04-23 |
| EAR PROBES (K822568) | Kelleher Corp. | 1982-09-14 |
Recalls involving this device
No recalls on record reference this clearance.