OIV · Dental Amalgam
Dental · 21 CFR 872.3070 · Class 2
Overview
| Product Code | OIV |
|---|---|
| Device Name | Dental Amalgam |
| Regulation | 21 CFR 872.3070 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
Dental amalgam is a device that consists of a combination of elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam alloy composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predosed capsule form, for the direct filling of carious lesions or structural defects in teeth. This device also includes the individual component devices, mercury and amalgam alloy, when intended to be combined with each other to form dental amalgam.
Classification Rationale
Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.” See § 872.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.”*See* § 872.1(e) for the availability of this guidance document.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K223182 | Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy | Worldwork S.R.L | May 1, 2023 | SESE |
| K140125 | NEW STETIC DENTAL AMALGAM ALLOY | New Stetic | Apr 29, 2014 | SESE |
| K081273 | ULTRACAPS S | Sdi , Ltd. | Jul 10, 2008 | SESE |
Top Applicants
- Worldwork S.R.L — 1 clearance
- Sdi , Ltd. — 1 clearance
- New Stetic — 1 clearance
