510(k) K771214
- Device
- SUPERFINE DIAMONDS
- Applicant
- Den-Mat Corp.
- 510(k) number
- K771214
- Product code
- EJL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-07-15
- Date received
- 1977-07-05
- Regulation
- 872.3240
- Classification name
- Bur, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3004130302
- 3013946322
- 1038806
- 3032163716
- 3008770655
- 2023633
- 3012422333
- 3007518363
- 3015967359
- 1718912
- 3015276580
- 3021284315
- 3010392243
- 9616696
- 3045857207
- 8021041
- 3032027578
- 1627417
- 1032227
- 3002692886
- 3006592743
- 3011210208
- 1836161
- 1526534
- 3030089802
- 3033011342
- 1044031
- 3045811395
- 3010145273
- 3013022399
- 3011539071
- 8031011
- 3007283751
- 3001561923
- 3017835246
- 3002966425
- 3013547803
- 3003444492
- 3010667863
- 3008582406
- 3011554142
- 3004193466
- 1000439711
- 3005621335
- 3005972890
- 9615845
- 2245304
- 2086043
- 3008496301
- 3008902714
- 3004425647
- 3003487388
- 9613866
- 8040278
- 2916735
- 1316408
- 3007791573
- 2531684
- 9613375
- 3024819505
- 3012336822
- 1058584
- 3010656982
- 2245654
- 1066741
- 9614438
- 3006316962
- 3005440795
- 3002807310
- 2024949
- 8020994
- 2436918
- 9614977
- 3027615
- 3009161350
- 2246821
- 3001616037
- 3042285073
- 1828288
- 3017498782
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 |