ENDODONTIC PAPERPOINTS
FDA 510(k) clearance K821625 · decided 1982-06-14
Clearance details
- K-number
- K821625
- Device name
- ENDODONTIC PAPERPOINTS
- Applicant
- Roeko
- Decision
- Substantially Equivalent
- Date received
- 1982-06-02
- Decision date
- 1982-06-14
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- EKN
- Device class
- 1
- Regulation number
- 872.3830
- 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 |
|---|---|---|
| ABSORBENT ENDODONTIC POINT (K843017) | United Dental Mfg., Inc. | 1985-01-09 |
| ENDODONTIC PAPER POINTS (K812886) | United Dental Mfg., Inc. | 1981-11-16 |
| PREMIER ABSORBENT POINTS (K800827) | Premier Dental Products Co. | 1980-04-29 |
| R&R ABSORBENT POINTS (K781605) | Ransom and Randolph | 1978-10-10 |
| ABSORBENT POINTS (K761203) | Johnson & Johnson Professionals, Inc. | 1976-12-13 |
| ENDODONTIC INSTRUMENTS (K760983) | Adp Intl., Inc. | 1976-11-15 |
Recalls involving this device
No recalls on record reference this clearance.