DZD — Tube, Orthodontic Class I
FDA product code DZD covers "Tube, Orthodontic", a Class I medical device regulated under 21 CFR 872.5410. Submissions are reviewed by the Dental panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DZD
- Device Class
- Class I
- Regulation Number
- 872.5410
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K943421 | jon-ko products | ORTHODONITC ELASTOMERIC SLEEVING | May 23, 1995 |
| K936243 | ortho specialties | REGENCY TUBE | February 2, 1994 |
| K935143 | dentauraum | DENTAURUM STAINLESS STEEL TUBING | January 31, 1994 |
| K911399 | aequitron medical | NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) | September 19, 1991 |
| K896586 | percussionaire | RATE INCREASE FOR IPPB/IPV | January 9, 1990 |
| K834446 | alexotek | ALEXOTEK LINGUAL TUBES | April 5, 1984 |
| K834392 | alexotek | LABIAL CUSPID TUBE | February 28, 1984 |
| K780205 | rocky mountain orthodontics | ORTHODONTIC BUCCAL TUBE | February 16, 1978 |