The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Micropower Hand Piece: Oral Max High Speed Drill.
| Device ID | K060270 |
| 510k Number | K060270 |
| Device Name: | MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL |
| Classification | Drill, Bone, Powered |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Elizabeth Paul |
| Correspondent | Elizabeth Paul LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-01 |
| Decision Date | 2006-04-10 |
| Summary: | summary |