K935856 is an FDA 510(k) clearance for the DENTAURUM SPACE MAINTAINER. This device is classified as a Maintainer, Space Preformed, Orthodontic (Class I - General Controls, product code DYT).
Submitted by Dentauraum, Inc. (Newtown, US). The FDA issued a Cleared decision on April 28, 1994, 141 days after receiving the submission on December 8, 1993.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5525.
| 510(k) Number | K935856 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 1993 |
| Decision Date | April 28, 1994 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | DYT — Maintainer, Space Preformed, Orthodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.5525 |