The following data is part of a premarket notification filed by Thunder Tiger Corp. with the FDA for Dental Air-powered Handpiece, Models Tiger 300t, 300k, 300w, 300b And 300n.
| Device ID | K062812 |
| 510k Number | K062812 |
| Device Name: | DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | THUNDER TIGER CORP. 58 FU-CHIUN STREET Hsin Chu City, TW 300 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min THUNDER TIGER CORP. 58 FU-CHIUN STREET Hsin Chu City, TW 300 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-19 |
| Decision Date | 2006-11-28 |
| Summary: | summary |