510(k) K761275
- Device
- AIROTOS LF HANDPIECE
- Applicant
- Dentsply Intl.
- 510(k) number
- K761275
- Product code
- DZA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-12-23
- Date received
- 1976-12-20
- Regulation
- 872.4130
- Classification name
- Drill, Dental, Intraoral
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2433629
- 3007842672
- 1525838
- 3008559238
- 3005554774
- 9680939
- 3025338240
- 3009325911
- 9611385
- 1000303432
- 3013557697
- 3011713204
- 3011891801
- 3007791573
- 3014829979
- 1054986
- 8031050
- 8031011
- 8010468
- 3002807310
- 3008249935
- 3004730368
- 3004726107
- 3006186796
- 3011390931
- 3011526299
- 3002966425
- 8020776
- 3010392243
- 3011276344
- 3017352116
- 9611450
- 3006765435
- 3003394081
- 3044819802
- 8010908
- 3040362639
- 9611367
- 3009514134
- 1063774
- 3007126709
- 3003418325
- 3030089802
- 3038632739
- 3003231822
- 8043554
- 3006110126
- 3004569445
- 3009848796
- 3012101632
- 3013946322
- 3021630667
- 3031886796
- 3011554142
- 3007649394
- 3015218457
- 3007622273
- 8030870
- 3013102320
- 2515379
- 3012322979
- 3005663340
- 3013271380
- 3009850967
- 3009460127
- 3042971970
- 8010445
- 9613230
- 3031493119
- 3011170140
- 8043962
- 3012421607
- 3008388427
- 3011210208
- 3010453282
- 3012101664
- 3006542438
- 3009611645
- 3018097239
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DZA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K984508 | SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD | W&H Dentalwerk Buermoos GmbH | 1999-06-25 |
| K962979 | S-53 INTRORAL DENTAL SYSTEM | Del Medical Systems Corp. | 1996-09-25 |
| K954790 | PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS | Tulsa Dental Products, Ltd. | 1996-01-16 |
| K914724 | ADA SHANK EXTENSION | Implant Corp. of America | 1993-07-27 |
| K905418 | GATES GLIDDEN DRILLS | The Hygenic Corp. | 1991-07-25 |
| K901097 | FILLOCK REAMER | Ivoclar North America, Inc. | 1990-04-25 |
| K896149 | ANEST-EZE DENTAL DRILL RA#2 | Signature One Products, Inc. | 1990-01-19 |
| K884187 | INDENTEC DRILL RA #1 | Phillip C. Crawford, D.D.S. | 1988-12-22 |
| K811113 | RIESS-LUHR | Allomedic | 1981-06-16 |
| K801887 | DRILL, DENTAL | Aesculap Instruments Corp. | 1980-08-20 |
| K801888 | HANDPIECE, DENTAL | Aesculap Instruments Corp. | 1980-08-20 |
| K760956 | SURGICAL MICRO DRILL | American Safety Equipment Corp. | 1976-11-19 |