KCQ · Tube Impression And Matrix
Dental · 21 CFR 872.6570 · Class 1
Overview
| Product Code | KCQ |
|---|---|
| Device Name | Tube Impression And Matrix |
| Regulation | 21 CFR 872.6570 |
| Device Class | Class 1 |
| Review Panel | Dental |
| GMP Exempt | Yes |
Identification
An impression tube is a device consisting of a hollow copper tube intended to take an impression of a single tooth. The hollow tube is filled with impression material. One end of the tube is sealed with a softened material, such as wax, the remaining end is slipped over the tooth to make the impression.
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 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K896621 | L.T.C. REPLACEMENT GASTROSTOMY TUBE | Intl. Medical Marketing, Inc. | Mar 13, 1990 | SESE |
Top Applicants
- Intl. Medical Marketing, Inc. — 1 clearance
