EHB · Collimator, X-Ray
Dental · 21 CFR 872.1840 · Class 1
Overview
| Product Code | EHB |
|---|---|
| Device Name | Collimator, X-Ray |
| Regulation | 21 CFR 872.1840 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A dental x-ray position indicating device is a device, such as a collimator, cone, or aperture, that is used in dental radiographic examination. The device is intended to align the examination site with the x-ray beam and to restrict the dimensions of the dental x-ray field by limiting the size of the primary x-ray beam.
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.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K921355 | WINGMASTER | Innovators, Inc. | Sep 25, 1992 | SESE |
| K903012 | AUDIOPRAT ENDOSCOPE | S.C.D.P.I. of Florida, Inc. | Oct 9, 1990 | SESE |
| K834606 | X-RAY COLLIMATOR X-CJD | Knochen Dental Laboratory | Feb 21, 1984 | SESE |
| K833558 | X-RAY SHIELD | Moyco Industries, Inc. | Jan 13, 1984 | SESE |
| K781675 | X-RAY COLLIMATOR | General X-Ray, Inc. | Dec 4, 1978 | SESE |
Top Applicants
- S.C.D.P.I. of Florida, Inc. — 1 clearance
- Moyco Industries, Inc. — 1 clearance
- Knochen Dental Laboratory — 1 clearance
- Innovators, Inc. — 1 clearance
- General X-Ray, Inc. — 1 clearance
