EGZ · Holder, Film, X-Ray
Dental · 21 CFR 872.1905 · Class 1
Overview
| Product Code | EGZ |
|---|---|
| Device Name | Holder, Film, X-Ray |
| Regulation | 21 CFR 872.1905 |
| Device Class | Class 1 |
| Review Panel | Dental |
| GMP Exempt | Yes |
Identification
A dental x-ray film holder is a device intended to position and to hold x-ray film inside the mouth.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K913168 | SALIBAG | Nix Co. , Ltd. | Sep 6, 1991 | SESE |
| K913160 | ID-TAB | Nix Co. , Ltd. | Sep 6, 1991 | SESE |
| K890355 | DENTAL X-RAY BITE BLOCK | Bite-A-Block | Jun 12, 1989 | SESE |
| K853451 | TROLL-BITE | Trollplast, Inc. | Jan 21, 1986 | SESE |
| K852170 | EZX YELLOW, BLUE OR ORANGE | Strong Marketing | Sep 5, 1985 | SESE |
| K853005 | S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM | The S. S. White Co. | Aug 13, 1985 | SESE |
| K813378 | UNI-BITE DENTAL X-RAY FILM HOLDER | Rinn Corp. | Jan 29, 1982 | SESE |
| K801079 | KWIX-BITE X-RAY FILM HOLDER | Henry Schein, Inc. | May 20, 1980 | SESE |
Top Applicants
- Nix Co. , Ltd. — 2 clearances
- Trollplast, Inc. — 1 clearance
- The S. S. White Co. — 1 clearance
- Strong Marketing — 1 clearance
- Rinn Corp. — 1 clearance
