510(k) K910794
- Device
- SMALL INSTRUMENT STERILIZATION/BUR BOX
- Applicant
- BREVET, INC.
- 510(k) number
- K910794
- Product code
- EJL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-05-23
- Date received
- 1991-02-25
- Regulation
- 872.3240
- Classification name
- Bur, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- TIMOTHY DIAMOND
- Address
- 3630 Miraloma P.O. Box 17713 Anahem CA US 92806 92806
FDA Registration Numbers#
- 3010656982
- 3012421607
- 3005554774
- 2183301
- 3017569338
- 3011649314
- 3030671632
- 3003394081
- 3019381139
- 9614438
- 3021023132
- 3035693034
- 3013641573
- 1526534
- 3003882387
- 3011210208
- 1316408
- 3002820615
- 1824299
- 3042285073
- 3005809810
- 3017835246
- 8030052
- 8030637
- 3012628066
- 9614986
- 3005515228
- 3006098230
- 3044150131
- 3022296393
- 8030870
- 3027615
- 3009848796
- 9613079
- 2018957
- 2916440
- 1223843
- 1833986
- 2245654
- 9611611
- 3001561923
- 3006316962
- 3004417597
- 3004158247
- 1420089
- 8043621
- 3011306962
- 3015060193
- 2133714
- 3007518363
- 3040335671
- 3031582434
- 1526352
- 3030531648
- 3038718579
- 3009171220
- 3009161350
- 3010155648
- 3002808270
- 2023950
- 3027248132
- 3005176727
- 3030089802
- 8031010
- 3008902714
- 1066741
- 8031058
- 3009348866
- 2027754
- 3012101632
- 9681565
- 3010160527
- 3004569445
- 8030938
- 3008388248
- 3011554142
- 3009732568
- 3011539071
- 3015422158
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EJL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K080687 | SMARTBURS | S.S. White Burs, Inc. | 2008-06-20 |
| K071352 | CERADRILL | Gebr. Brasseler GmbH & Co. KG | 2007-06-29 |
| K061383 | BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS | B.T.I. Biotechnology Institute, Sl. | 2006-08-03 |
| K943273 | TRI HAWK BUR, FG BUR | Tri Hawk Corp. | 1994-08-01 |
| K926205 | MONOSTERYL | Utensili Super Abrasivi | 1994-02-10 |
| K923883 | DENTAL OR SURGICAL BUR | Stratum Dental Technologies, Inc. | 1993-07-27 |
| K921406 | SILICONT BUR BLOCK | Innovators, Inc. | 1992-04-28 |
| K920243 | SMART BURS TOTAL CARBIDES | Vermont Diamond Instruments | 1992-03-25 |
| K911208 | TIN COATED DENTAL BURS | Surgical Precision Instruments, Corp. | 1991-09-16 |
| K882183 | DENTAL BURS | Tri-Stage, Inc. | 1988-06-21 |
| K873698 | STERILIZED DENTAL BIT PACKAGING | Florida Diamond Instruments Corp. | 1987-12-03 |
| K863097 | CB BUR | Beavers Dental, Div. Sybron Canada, Ltd. | 1986-08-26 |
| K854690 | DIAMONDS BURS-COMPOSIT FINISHING | Almore Intl., Inc. | 1986-03-25 |
| K854691 | DIAMOND BURS-HANDPIECE | Almore Intl., Inc. | 1986-03-25 |
| K842720 | BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL | Penn-Med Technology, Inc. | 1985-05-21 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases