The following data is part of a premarket notification filed by World Bio Tech Co., Ltd with the FDA for Mach Brackets Bright Brackets.
| Device ID | K120471 |
| 510k Number | K120471 |
| Device Name: | MACH BRACKETS BRIGHT BRACKETS |
| Classification | Bracket, Ceramic, Orthodontic |
| Applicant | WORLD BIO TECH CO., LTD 300 ATWOOD Pittsburgh, PA 15213 |
| Contact | Peter Chung |
| Correspondent | Peter Chung WORLD BIO TECH CO., LTD 300 ATWOOD Pittsburgh, PA 15213 |
| Product Code | NJM |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-16 |
| Decision Date | 2012-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885797004260 | K120471 | 000 |