The following data is part of a premarket notification filed by Thunder Tiger Corp. with the FDA for Vigor A Low Speed Air Motor, Vigor C Low Speed Contra-angle Handpieces, Vigor S Low Speed Straight Handpieces.
| Device ID | K112305 |
| 510k Number | K112305 |
| Device Name: | VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | THUNDER TIGER CORP. NO. 7, 6TH ROAD INDUSTRY PARK Taichung, TW 40755 |
| Contact | Jo Lee |
| Correspondent | Jo Lee THUNDER TIGER CORP. NO. 7, 6TH ROAD INDUSTRY PARK Taichung, TW 40755 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-11 |
| Decision Date | 2012-04-17 |
| Summary: | summary |