510(k) K901262
- Device
- F.g. Laser (dental Bur)
- Applicant
- DIAMOND ROTARY AND CARBIDE INTL.
- 510(k) number
- K901262
- Product code
- DZP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-07-09
- Date received
- 1990-03-16
- Regulation
- 872.4535
- Classification name
- Instrument, Diamond, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- J WILLOUGHBY
- Address
- P.O. Box 3092 Winnipeg, Manitoba Canada R3c 4e5 CA
FDA Registration Numbers#
- 3005176727
- 9614948
- 2029275
- 2023633
- 1525838
- 2245654
- 9680740
- 3006990004
- 3030515618
- 3006765435
- 3034729565
- 9611505
- 3005809810
- 3009348866
- 3012832388
- 3002820615
- 9615845
- 8010516
- 3012628066
- 3004569445
- 2245304
- 3002808270
- 3008770655
- 8030343
- 3007791573
- 3011554142
- 8030052
- 3021023132
- 1035766
- 3000268902
- 2020356
- 8030938
- 1937100
- 1836088
- 3009171220
- 3011191212
- 3003399707
- 3012501675
- 2511556
- 8031010
- 3012627824
- 2024980
- 8010468
- 3038718579
- 3043303267
- 2916440
- 8031011
- 3008249935
- 1316367
- 2515379
- 2520265
- 1526534
- 3011575061
- 2416455
- 8040278
- 3002807315
- 3009732568
- 8043621
- 8020994
- 1032227
- 3004425647
- 8021041
- 3003418325
- 1836161
- 3015136927
- 9614977
- 3002807310
- 3030015903
- 2523990
- 3003444492
- 9611611
- 9614987
- 3001124136
- 3030126955
- 2245590
- 3002808149
- 3003963832
- 3014329459
- 2183301
- 3012494290
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DZP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K120037 | BLUWHITE DIAMOND DENTAL BURS MODIFIED | Beavers Dental, Div. Sybron Canada, Ltd. | 2012-04-20 |
| K943841 | SOPHOS DENTAL DIAMOND | Sophos Technologic | 1994-09-16 |
| K940908 | DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS | Dunhall Pharmaceuticals, Inc. | 1994-08-29 |
| K934981 | DENTAL DRILL | Eare Consulting Service | 1994-02-03 |
| K923757 | DENTAL DIAMOND DRILLS | Alpha Industrializacao DE Metais Ltda. | 1993-03-16 |
| K913651 | MANI DIA-BURS | The Lahr Consulting Group, Inc. | 1992-01-14 |
| K901967 | DENDIA WERK BURS AND CUTTING DISCS | Micro-Aire Surgical Instruments, Inc. | 1990-07-13 |
| K900089 | FG DIAMOND BURRS | Kab Gloves Unltd. | 1990-04-03 |
| K893844 | 3D DENTAL DIAMOND ROTARY INSTRUMENTS | Lustgarten Multi-Tech International, Inc. | 1989-08-11 |
| K885233 | NOVA DIAMOND | Microcopy, Div. Neo-Flo, Inc. | 1989-02-13 |
| K880179 | BEAVERS' DENTAL DIAMOND INSTRUMENTS | Beavers Dental, Div. Sybron Canada, Ltd. | 1988-03-09 |
| K871639 | DENTAL DIAMOND BURS | E&D Dental Manufacturing Co. | 1987-05-18 |
| K854347 | HYBRID POINTS | Shofu Dental Corp. | 1985-12-27 |
| K833038 | SUMMA DISK | Shofu Dental Corp. | 1983-10-04 |
| K832856 | GINGI CURETTAGE DIAMOND POINTS | Shofu Dental Corp. | 1983-10-04 |