BAR & RIDER, SCREWS, TUBES
FDA 510(k) clearance K790078 · decided 1979-02-27
Clearance details
- K-number
- K790078
- Device name
- BAR & RIDER, SCREWS, TUBES
- Applicant
- Eurodent, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-01-10
- Decision date
- 1979-02-27
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- ECG
- Device class
- 1
- Regulation number
- 872.6710
- 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 |
|---|---|---|
| EAGLE DS (K895164) | American Sterilizer Co. | 1989-11-17 |
| CITOMAT AUTOCLAVES (K843234) | Lic-Orthion | 1984-10-25 |
| MAGNETIC RETENTION UNIT (K811237) | Universiti Malaya | 1981-06-16 |
| ENDODONTIC POST SYSTEMS (K810977) | Preat Corp. | 1981-05-13 |
| NEY EQUI-HINGE (K790290) | Deringer-Ney, Inc. | 1979-04-10 |
| STEAM STERILIZER (K771266) | Amsco Hospital Products Co. | 1977-08-02 |
Recalls involving this device
No recalls on record reference this clearance.