510(k) K882183
- Device
- DENTAL BURS
- Applicant
- TRI-STAGE, INC.
- 510(k) number
- K882183
- Product code
- EJL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-06-21
- Date received
- 1988-05-24
- 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
- ALAN DONALD
- Address
- 5897 Oberlin Dr. #205 San Diego CA US 92121 92121
FDA Registration Numbers#
- 2523320
- 3009848796
- 1424785
- 9614438
- 3010155648
- 3031582434
- 3024819505
- 9611611
- 3010251542
- 3008346537
- 3008582406
- 9613375
- 3005440795
- 1038806
- 3030228577
- 2245654
- 3012628066
- 1833986
- 2023633
- 3008496301
- 3009551666
- 3043149181
- 3010864832
- 3010606154
- 3009482106
- 2436918
- 1223843
- 3003882387
- 3008370577
- 3043648115
- 9611450
- 3005176727
- 3030015903
- 8031050
- 9611458
- 1066741
- 3002820615
- 8030343
- 3009348866
- 9611367
- 3015276580
- 1824299
- 3001616037
- 1526534
- 3008887731
- 3042285073
- 3003418325
- 3012322979
- 1815540
- 3005972890
- 3030220361
- 3038718579
- 3013022399
- 2018957
- 3011808221
- 3030126955
- 3003877407
- 3007791573
- 8030870
- 3012477813
- 3008388248
- 3033011342
- 2024980
- 2086043
- 3006942526
- 3045857207
- 3011713204
- 3011526299
- 3019381139
- 3003988575
- 1316367
- 3022516928
- 3009968482
- 2027062
- 3012421607
- 2245304
- 9615845
- 2437780
- 3014540272
- 8020994
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 |
| 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#
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FDA Review#
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