Holder, Film, X-Ray
The X-Ray Film Holder is a dental accessory used to position and stabilize intraoral radiographic film within the patient's mouth during X-ray exposure, ensuring accurate film placement and reproducible image geometry. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EGZ, regulated under 21 CFR 872.1905 in the Dental (DE) specialty. This device is exempt from Good Manufacturing Practice (GMP/QSR) requirements.
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Basic Information
- Product Code
- EGZ
- Device Class
- FDA class 1
- Regulation Number
- 872.1905
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K913168 | SALIBAG | Sep 06, 1991 | Substantially Equivalent | Nix Co. , Ltd. |
| K913160 | ID-TAB | Sep 06, 1991 | Substantially Equivalent | Nix Co. , Ltd. |
| K890355 | DENTAL X-RAY BITE BLOCK | Jun 12, 1989 | Substantially Equivalent | Bite-A-Block |
| K853451 | TROLL-BITE | Jan 21, 1986 | Substantially Equivalent | Trollplast, Inc. |
| K852170 | EZX YELLOW, BLUE OR ORANGE | Sep 05, 1985 | Substantially Equivalent | Strong Marketing |
| K853005 | S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM | Aug 13, 1985 | Substantially Equivalent | The S. S. White Co. |
| K813378 | UNI-BITE DENTAL X-RAY FILM HOLDER | Jan 29, 1982 | Substantially Equivalent | Rinn Corp. |
| K801079 | KWIX-BITE X-RAY FILM HOLDER | May 20, 1980 | Substantially Equivalent | Henry Schein, Inc. |
FEI Numbers
This FDA classification entry is associated with 124 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 124 registration numbers. Click on an entry to view related FDA registrations.