The following data is part of a premarket notification filed by Dentalez Group, Stardental Division with the FDA for 430 Swl 45 And 430 Sw 45 High-speed Handpieces.
| Device ID | K130455 |
| 510k Number | K130455 |
| Device Name: | 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | DENTALEZ GROUP, STARDENTAL DIVISION 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Contact | Jim Watkins |
| Correspondent | Jim Watkins DENTALEZ GROUP, STARDENTAL DIVISION 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-22 |
| Decision Date | 2013-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7022658220 | K130455 | 000 |
| D7022658210 | K130455 | 000 |