510(k) K842720
- Device
- Bur, Dental Gutta Percha-file-pulp Canal
- Applicant
- PENN-MED TECHNOLOGY, INC.
- 510(k) number
- K842720
- Product code
- EJL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-05-21
- Date received
- 1984-07-13
- 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#
- 3022082678
- 3008388248
- 3005176727
- 3011713204
- 9614948
- 2029275
- 3006316962
- 2916735
- 3033011342
- 9614986
- 9613866
- 3002966425
- 2023633
- 1525838
- 2245654
- 3015422158
- 2246821
- 9611450
- 3013538161
- 3033197029
- 3038632739
- 1420089
- 3009161350
- 3027615
- 1627417
- 3006540014
- 3010392243
- 3008346537
- 2086043
- 1723412
- 3005809810
- 3001617766
- 3011117802
- 3010251542
- 3012322979
- 3042285073
- 3032378317
- 3031582434
- 3011539071
- 3004362293
- 3009482106
- 3009348866
- 3009968482
- 3002820615
- 9615845
- 3030671632
- 3004730002
- 3043648115
- 8010516
- 3012628066
- 3002570326
- 3004569445
- 2081322
- 2245304
- 3011936113
- 2918719
- 3002808270
- 1424785
- 3008770655
- 8030343
- 3040335671
- 3008323540
- 3007791573
- 3011554142
- 1000439711
- 3009737865
- 8030052
- 3021023132
- 3014540272
- 3004417597
- 8030938
- 1937100
- 2024949
- 3009171220
- 3019381139
- 3009848796
- 3007649394
- 3022296393
- 3038187461
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 |