KZO · Ink, Arch Tracing
Dental · 21 CFR 872.3150 · Class 1
Overview
| Product Code | KZO |
|---|---|
| Device Name | Ink, Arch Tracing |
| Regulation | 21 CFR 872.3150 |
| Device Class | Class 1 |
| Review Panel | Dental |
| GMP Exempt | Yes |
Identification
An articulator is a mechanical device intended to simulate movements of a patient's upper and lower jaws. Plaster casts of the patient's teeth and gums are placed in the device to reproduce the occlusion (bite) and articulation of the patient's jaws. An articulator is intended to fit dentures or provide orthodontic treatment.
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, the device 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K810972 | THE GNATHOMETER-M | Bauer, Cheng & Associates, Inc. | May 5, 1981 | SESE |
| K771176 | GOTHIC ARCH TRACING | Dentsply Intl. | Aug 16, 1977 | SESE |
Top Applicants
- Dentsply Intl. — 1 clearance
- Bauer, Cheng & Associates, Inc. — 1 clearance
