The following data is part of a premarket notification filed by Coltene/whaledent Inc. with the FDA for Perfect Tissue Contouring System Ii.
| Device ID | K071632 |
| 510k Number | K071632 |
| Device Name: | PERFECT TISSUE CONTOURING SYSTEM II |
| Classification | Unit, Electrosurgical, And Accessories, Dental |
| Applicant | COLTENE/WHALEDENT INC. 235 ASCOT PARKWAY Cuyahoga Falls, OH 44223 |
| Contact | Glenn Persello |
| Correspondent | Glenn Persello COLTENE/WHALEDENT INC. 235 ASCOT PARKWAY Cuyahoga Falls, OH 44223 |
| Product Code | EKZ |
| CFR Regulation Number | 872.4920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-14 |
| Decision Date | 2007-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D661S8FSRK0 | K071632 | 000 |
| D661S6000A1 | K071632 | 000 |
| D661S6005A0 | K071632 | 000 |
| D661S6007A0 | K071632 | 000 |
| D661S6008A0 | K071632 | 000 |
| D661S6008CE0 | K071632 | 000 |
| D661S6010A0 | K071632 | 000 |
| D661S6011A0 | K071632 | 000 |
| D661S6012A0 | K071632 | 000 |
| D661S6013A0 | K071632 | 000 |
| D661S6014A0 | K071632 | 000 |
| D661S6015A0 | K071632 | 000 |
| D661S6016A0 | K071632 | 000 |
| D661S6017A0 | K071632 | 000 |
| D661S6018A0 | K071632 | 000 |
| D661S70010 | K071632 | 000 |
| D661S7010A0 | K071632 | 000 |
| D661S81150 | K071632 | 000 |
| D661S2130 | K071632 | 000 |