The following data is part of a premarket notification filed by Mectron Spa with the FDA for Piezosurgery Touch, Piezosurgery White.
| Device ID | K171958 |
| 510k Number | K171958 |
| Device Name: | PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE |
| Classification | Drill, Bone, Powered |
| Applicant | Mectron SPA Via Loreto 15 Carasco, IT 16042 |
| Contact | Franco Zunino |
| Correspondent | Roger Gray Donawa Lifescience Consulting Srl Piazza Albania 10 Rome, IT 00153 |
| Product Code | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-29 |
| Decision Date | 2018-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E322033900080 | K171958 | 000 |
| E322033900070 | K171958 | 000 |
| E322033900060 | K171958 | 000 |
| E322033800130 | K171958 | 000 |
| E322033700280 | K171958 | 000 |
| E322033700270 | K171958 | 000 |
| E322033700260 | K171958 | 000 |
| E322033700250 | K171958 | 000 |