510(k) K874374
- Device
- The Woog Oratest
- Applicant
- WOOG INTL.
- 510(k) number
- K874374
- Product code
- EAZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-01-19
- Date received
- 1987-10-26
- Regulation
- 872.4630
- Classification name
- Light, Operating, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- HELLER, JR
- Address
- 1848 Charter Ln., Suite C Lancaster PA US 17601 17601
FDA Registration Numbers#
- 3016367529
- 3006799849
- 3023443842
- 3043149181
- 3003548115
- 3009774128
- 3027509245
- 1054713
- 3010373494
- 3019103
- 3002819275
- 3015136927
- 1523530
- 3004187094
- 1062917
- 3013734586
- 3004884150
- 9611445
- 8030876
- 3008559238
- 3017604
- 3015376465
- 3014766731
- 3014166037
- 3003694926
- 3014953747
- 3007695715
- 3003637274
- 3030089804
- 3006551266
- 3004082121
- 3022226
- 1017522
- 3015703934
- 3010446656
- 9614977
- 8043962
- 3039246551
- 2020475
- 3007607709
- 2085199
- 2916273
- 2024949
- 3004064895
- 3010493153
- 2087259
- 2183301
- 9681829
- 3005938413
- 3010106508
- 3036758824
- 3014683120
- 3010656982
- 3029780
- 3021023132
- 3002807636
- 3014980444
- 3008252115
- 3008770655
- 3009171220
- 3030089802
- 2018957
- 3025436467
- 1049061
- 3016798774
- 3007031016
- 2031508
- 3015729
- 3018418236
- 3020989
- 3011554142
- 3029972406
- 1413475
- 3006766059
- 3013403214
- 9616065
- 3006610845
- 3023861999
- 1721430
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EAZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K072309 | MICROLUX/BLU | Addent, Inc. | 2007-11-19 |
| K041614 | MICROLUX DL | Addent, Inc. | 2005-04-04 |
| K033033 | VIZILITE-BLUE ORAL EXAM KIT | Trylon Corp. | 2004-11-22 |
| K003995 | SPECULITE/ORALLITE | Trylon Corp. | 2001-03-16 |
| K926081 | DENTAL LIGHT | Mdt Corp., Inc. | 1994-01-26 |
| K935390 | SIROLUX FANTASTIC | Pelton & Crane Co. | 1993-12-10 |
| K925629 | ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT | Den-Tal-Ez Mfg Co., Inc. | 1993-11-23 |
| K923462 | DELIGHT | Planmeca USA, Inc. | 1992-12-21 |
| K912142 | MICRONAIRE ISO-HOOD MAX 5UV | Micronaire Corp. | 1991-10-30 |
| K912997 | MINIFLEX AND PERSONAL UNIT | Dabi-Atlante America Corp. | 1991-10-30 |
| K902685 | DEFIANCE MODEL FUS 336 | Defiance Electronics, Inc. | 1990-09-17 |
| K894059 | ISOLIGHT | Eurodent, Inc. | 1989-09-07 |
| K893044 | A-DEC DENTAL LIGHT | A-Dec, Inc. | 1989-07-14 |
| K891216 | DENTAL EQUIPMENT PROTECTION DEVICES | Pro-Safe Professional Linens, Inc. | 1989-06-02 |
| K884223 | DENTAL LAMP HANDLE COVER | Steri-Shield Products, Inc. | 1989-03-17 |