510(k) K873698
- Device
- STERILIZED DENTAL BIT PACKAGING
- Applicant
- FLORIDA DIAMOND INSTRUMENTS CORP.
- 510(k) number
- K873698
- Product code
- EJL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-12-03
- Date received
- 1987-09-14
- 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
- SCHNEIDER
- Address
- 1429 Colonial Blvd. Fort Myers FL US 33907 33907
FDA Registration Numbers#
- 3022516928
- 3027248132
- 1525838
- 3015422158
- 3005554774
- 3005972890
- 1824299
- 3010160527
- 9611385
- 3006942526
- 3011713204
- 3007791573
- 3014829979
- 8031050
- 1222993
- 3009348866
- 3015967359
- 3042866301
- 3027615
- 3005176727
- 8031011
- 8010468
- 3011117802
- 2027754
- 3002807310
- 3015276580
- 3011526299
- 3002966425
- 3030531648
- 3010392243
- 9611450
- 3006017180
- 3005515228
- 3011306962
- 3003394081
- 3023339159
- 3044819802
- 9611367
- 2126683
- 3044150131
- 2411056
- 9614404
- 3008496301
- 3008346537
- 8021041
- 3032027578
- 3003418325
- 3030089802
- 3038632739
- 8043554
- 9614987
- 3013022399
- 3013547803
- 8031058
- 3012627824
- 3004569445
- 3009848796
- 3009551666
- 3012101632
- 3045076248
- 3013946322
- 3010667863
- 3004158247
- 3031886796
- 1058584
- 1723412
- 3011554142
- 3007649394
- 8020994
- 3017498782
- 8030870
- 2245304
- 1833132
- 3040602659
- 3005831677
- 8030637
- 1038806
- 3008902714
- 3012322979
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 |
| 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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