The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Supertorque High-speed Handpieces And Gentlepower Handpieces And Attachements.
| Device ID | K073478 |
| 510k Number | K073478 |
| Device Name: | SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 W. COLLINS AVE. Orange, CA 92867 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell SYBRON DENTAL SPECIALTIES, INC. 1717 W. COLLINS AVE. Orange, CA 92867 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-11 |
| Decision Date | 2008-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV100445030 | K073478 | 000 |
| EKAV100192580 | K073478 | 000 |
| EKAV100189930 | K073478 | 000 |
| EKAV100174540 | K073478 | 000 |
| EKAV100174530 | K073478 | 000 |
| EKAV100156600 | K073478 | 000 |
| EKAV100145030 | K073478 | 000 |
| EKAV100122780 | K073478 | 000 |
| EKAV055316000 | K073478 | 000 |
| EKAV100209110 | K073478 | 000 |
| EKAV100236930 | K073478 | 000 |
| EKAV100444560 | K073478 | 000 |
| EKAV100443750 | K073478 | 000 |
| EKAV100369770 | K073478 | 000 |
| EKAV100369760 | K073478 | 000 |
| EKAV100322780 | K073478 | 000 |
| EKAV100311090 | K073478 | 000 |
| EKAV100311080 | K073478 | 000 |
| EKAV100311070 | K073478 | 000 |
| EKAV055313900 | K073478 | 000 |
| EKAV055312100 | K073478 | 000 |
| EKAV054083400 | K073478 | 000 |
| EKAV053456600 | K073478 | 000 |
| EKAV053456500 | K073478 | 000 |
| EKAV052456200 | K073478 | 000 |
| EKAV052456100 | K073478 | 000 |
| EKAV052456000 | K073478 | 000 |
| EKAV100960480 | K073478 | 000 |
| 10194665004545 | K073478 | 000 |
| 10194665004514 | K073478 | 000 |
| EKAV053456700 | K073478 | 000 |
| EKAV053552000 | K073478 | 000 |
| EKAV053562200 | K073478 | 000 |
| EKAV053562100 | K073478 | 000 |
| EKAV053562000 | K073478 | 000 |
| EKAV053561900 | K073478 | 000 |
| EKAV053561800 | K073478 | 000 |
| EKAV053552600 | K073478 | 000 |
| EKAV053552500 | K073478 | 000 |
| EKAV053552100 | K073478 | 000 |
| 10194665004491 | K073478 | 000 |
| EKAV100453800 | K073478 | 000 |
| EKAV100732010 | K073478 | 000 |
| EKAV100818340 | K073478 | 000 |
| EKAV100818330 | K073478 | 000 |
| EKAV100818320 | K073478 | 000 |
| EKAV100818310 | K073478 | 000 |
| EKAV100818300 | K073478 | 000 |
| EKAV100818290 | K073478 | 000 |
| EKAV100818280 | K073478 | 000 |
| EKAV100818260 | K073478 | 000 |
| EKAV100818350 | K073478 | 000 |
| EKAV100849980 | K073478 | 000 |
| EKAV100731970 | K073478 | 000 |
| EKAV100175990 | K073478 | 000 |
| EKAV055315500 | K073478 | 000 |
| EKAV101030000 | K073478 | 000 |
| EKAV100981470 | K073478 | 000 |
| EKAV100863850 | K073478 | 000 |
| EKAV100863830 | K073478 | 000 |
| EKAV100849990 | K073478 | 000 |
| EKAV100818250 | K073478 | 000 |
| EKAV100818240 | K073478 | 000 |
| EKAV100818230 | K073478 | 000 |
| EKAV100687000 | K073478 | 000 |
| EKAV100664000 | K073478 | 000 |
| EKAV100643000 | K073478 | 000 |
| EKAV100638000 | K073478 | 000 |
| EKAV100608000 | K073478 | 000 |
| EKAV100601000 | K073478 | 000 |
| EKAV100464030 | K073478 | 000 |
| EKAV100464010 | K073478 | 000 |
| EKAV100692000 | K073478 | 000 |
| EKAV100735800 | K073478 | 000 |
| EKAV100818220 | K073478 | 000 |
| EKAV100755600 | K073478 | 000 |
| EKAV100755510 | K073478 | 000 |
| EKAV100755500 | K073478 | 000 |
| EKAV100755410 | K073478 | 000 |
| EKAV100755400 | K073478 | 000 |
| EKAV100755310 | K073478 | 000 |
| EKAV100755300 | K073478 | 000 |
| EKAV100454000 | K073478 | 000 |