The following data is part of a premarket notification filed by Thunder Tiger Corp. with the FDA for Dental Air-powered Handpiece, Models Tiger 100, 101, 200, 201 And 202.
| Device ID | K052822 |
| 510k Number | K052822 |
| Device Name: | DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202 |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | THUNDER TIGER CORP. 58 FU-CHIUN STREET Hsin Chu City, TW 300 |
| Contact | Ke Min Jen |
| Correspondent | Ke Min Jen 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 | 2005-10-04 |
| Decision Date | 2006-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00304040064382 | K052822 | 000 |
| 00304040064375 | K052822 | 000 |
| 00304040062074 | K052822 | 000 |
| 00304040062067 | K052822 | 000 |
| 00304040062005 | K052822 | 000 |
| 00304040061992 | K052822 | 000 |