UNI-BITE DENTAL X-RAY FILM HOLDER
FDA 510(k) clearance K813378 · decided 1982-01-29
Clearance details
- K-number
- K813378
- Device name
- UNI-BITE DENTAL X-RAY FILM HOLDER
- Applicant
- Rinn Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-12-01
- Decision date
- 1982-01-29
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- EGZ
- Device class
- 1
- Regulation number
- 872.1905
- 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 |
|---|---|---|
| SALIBAG (K913168) | Nix Co. , Ltd. | 1991-09-06 |
| ID-TAB (K913160) | Nix Co. , Ltd. | 1991-09-06 |
| DENTAL X-RAY BITE BLOCK (K890355) | Bite-A-Block | 1989-06-12 |
| TROLL-BITE (K853451) | Trollplast, Inc. | 1986-01-21 |
| EZX YELLOW, BLUE OR ORANGE (K852170) | Strong Marketing | 1985-09-05 |
| S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM (K853005) | The S. S. White Co. | 1985-08-13 |
| KWIX-BITE X-RAY FILM HOLDER (K801079) | Henry Schein, Inc. | 1980-05-20 |
Recalls involving this device
No recalls on record reference this clearance.