510(k) K780641
- Device
- DENTAL ROTARY CARBIDE BURS 76EJL
- Applicant
- TELEDYNE DENSCO
- 510(k) number
- K780641
- Product code
- EJL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-04-21
- Date received
- 1978-04-17
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3033197029
- 3038718579
- 3008323540
- 3005440795
- 9611385
- 2245304
- 3004425647
- 3023443842
- 3032378317
- 2132509
- 3043149181
- 3008582406
- 2523320
- 3009848796
- 8030870
- 3011117802
- 3014540272
- 2245654
- 3005176727
- 3015967359
- 9615845
- 3022296393
- 3038280066
- 9611450
- 3006098230
- 3008388248
- 3011210208
- 3010021780
- 3017910185
- 3003399707
- 1627417
- 2023950
- 8040278
- 3012322979
- 3004730002
- 1054713
- 3015422158
- 3006942526
- 3002966425
- 3017835246
- 9616696
- 2411797
- 3011302409
- 2416455
- 1223843
- 3004193466
- 8010468
- 3015136927
- 3010155648
- 3009142026
- 3015060193
- 3009737865
- 2027754
- 3031582434
- 3030531648
- 3013547803
- 3002808149
- 3021076825
- 1222993
- 3010160527
- 3001561923
- 2437780
- 3004362293
- 8030052
- 3040335671
- 3002808270
- 3006592743
- 8030938
- 1000439711
- 3011649314
- 3003120666
- 1815540
- 3033011342
- 3004130302
- 3008346537
- 9613866
- 2918719
- 3024819505
- 3012101632
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 |
| K910794 | SMALL INSTRUMENT STERILIZATION/BUR BOX | Brevet, Inc. | 1991-05-23 |
| 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 |
Legacy Summary#
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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