EJF — Bracket, Metal, Orthodontic Class I
FDA product code EJF covers "Bracket, Metal, Orthodontic", a Class I medical device regulated under 21 CFR 872.5410. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EJF
- 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 |
|---|---|---|---|
| K994357 | thermoelastic technologies | BITEM LOCK, MODELS SW006, SW012 | March 14, 2000 |
| K932825 | gac intl | MICROARCH GOLD BRACKET | May 9, 1994 |
| K933501 | unitek | ALASTIK | April 28, 1994 |
| K923372 | althan | MEMORY WIRE | April 22, 1994 |
| K933080 | orthotech | ORTHOTECH DURA-GOLD BARCKETS | March 23, 1994 |
| K935139 | dentauraum | FASCINATION CERAMIC BRACKET | February 4, 1994 |
| K936244 | mid-american dental specialties | REGENCY BRACKET | February 2, 1994 |
| K934881 | cdb | REFLECTIONS | February 1, 1994 |
| K935122 | dentauraum | DENTAURUM METAL BRACKETS | January 31, 1994 |
| K925028 | forestadent | FORESTADENT ORTHODONTIC BANDS | January 26, 1994 |
| K926427 | easy access orthodontics | LARIAT PALATE EXPANDER | January 26, 1994 |
| K930881 | dualtek | CHANNEL-EDGE BRACKET SYSTEM | January 21, 1994 |
| K933758 | mid-american dental specialties | REGENCY PLUS BRACKET | January 18, 1994 |
| K922806 | ormco | ORMCO SPORTSGUARD | October 20, 1993 |
| K932025 | gac intl | ION-IMPLANTED NEO SENTALLOY | September 13, 1993 |
| K925012 | american orthodontics | PLASTIC CHAIN | September 13, 1993 |
| K923218 | ortho organizers | NITANIUM PALATAL EXPANDER | September 13, 1993 |
| K931663 | ortho organizers | NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL | July 8, 1993 |
| K930452 | zulaf | SOLO TIES | July 8, 1993 |
| K924971 | forestadent bernhard forster | FORESTADENT BRACKETS | May 27, 1993 |