510(k) K905418
- Device
- Gates Glidden Drills
- Applicant
- THE HYGENIC CORP.
- 510(k) number
- K905418
- Product code
- DZA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-07-25
- Date received
- 1990-12-04
- Regulation
- 872.4130
- Classification name
- Drill, Dental, Intraoral
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MEYER
- Address
- 1245 Home Ave. Akron OH US 44310 44310
FDA Registration Numbers#
- 3031235905
- 3011713204
- 3030648980
- 3002966425
- 1525838
- 3001226627
- 9611450
- 3005115116
- 3022396768
- 3009611645
- 3015978392
- 3000203391
- 3038632739
- 3009161350
- 1627417
- 3006765435
- 3010392243
- 2086043
- 3009117991
- 3004726107
- 3013557697
- 2433629
- 3010251542
- 3012322979
- 3021630667
- 9680913
- 3018097239
- 3002907620
- 3009049852
- 3043648115
- 8010516
- 3009514134
- 3008388427
- 8010445
- 3004569445
- 3011170140
- 2918719
- 3011936113
- 3011891801
- 3008757014
- 8030343
- 3007791573
- 3011554142
- 3009737865
- 3021023132
- 3018662547
- 3003759558
- 8030938
- 3035983708
- 3005405362
- 3009528809
- 3013173272
- 3009171220
- 3009848796
- 9613230
- 3007649394
- 8010908
- 3003399707
- 3012501675
- 2511556
- 3011526299
- 8031010
- 3031886796
- 8020776
- 3015218457
- 2024980
- 3038718579
- 8010468
- 9615399
- 3001082453
- 3024858450
- 3025338240
- 3025325119
- 3003394081
- 3010864832
- 3009142026
- 3007842672
- 8031011
- 3010453282
- 3008249935
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 |
| 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 |
| K761275 | AIROTOS LF HANDPIECE | Dentsply Intl. | 1976-12-23 |
| K760956 | SURGICAL MICRO DRILL | American Safety Equipment Corp. | 1976-11-19 |