510(k) K860843
- Device
- Check-up Plaque Fighting Gum
- Applicant
- MINNETONKA, INC.
- 510(k) number
- K860843
- Product code
- EJR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-05-21
- Date received
- 1986-03-06
- Regulation
- 872.6030
- Classification name
- Agent, Polishing, Abrasive, Oral Cavity
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- JOHN L NEVEAUX
- Address
- P.O. Box 1a Minnetonka MN US 55343 55343
FDA Registration Numbers
- 3002789526
- 3005176727
- 1410097
- 3013584861
- 8030987
- 9612352
- 3003697084
- 3039433962
- 1525838
- 2246821
- 3014334038
- 1061053
- 3003982003
- 3006990004
- 1420089
- 3025436467
- 3006847937
- 3006611932
- 2241860
- 2086043
- 3015548849
- 3031582434
- 3009968482
- 3012187973
- 3004096429
- 3016075921
- 3043648115
- 2081322
- 8044038
- 3003637274
- 3002807050
- 3011554142
- 3008912871
- 3018662547
- 3032312561
- 8030938
- 1215305
- 1937100
- 9611959
- 3010131268
- 3009171220
- 1319130
- 8010908
- 2511556
- 2027375
- 3012627824
- 3011632
- 3008959450
- 2424472
- 9613208
- 2024980
- 3038718579
- 3026400121
- 9681210
- 1000272892
- 3010864832
- 1043617
- 2916440
- 2244812
- 3010002722
- 3011463882
- 1721647
- 3012101632
- 1316367
- 2515379
- 3005581016
- 3034731361
- 3025307990
- 2416455
- 3016965564
- 2087259
- 8020994
- 3002613208
- 1032227
- 3005628474
- 3023816720
- 9616762
- 3003418325
- 1836161
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EJR
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171189 | AIR-FLOW PLUS Prophylaxis powder | E.M.S Electro Medical Systems S.A | 2017-09-11 |
| K131760 | WHIP MIX PREPPIES PLUS | Whip-Mix Corp. | 2014-03-26 |
| K121698 | NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN | Dentsply International, Inc. | 2012-08-06 |
| K103114 | OSSPRAY SYLC CR | Osspray, Ltd. | 2011-03-14 |
| K102053 | BUTLER CALCI-FLOR PROPHYLAXIS PASTE | Sunstar Americas, Inc. | 2011-02-03 |
| K101104 | REMIN PRO | Voco GmbH | 2010-10-21 |
| K100539 | PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE | Preventive Technologies, Inc. | 2010-06-17 |
| K070854 | GC MI PASTE PLUS | GC America, Inc. | 2007-04-12 |
| K062502 | OSSPRAY CLEANING COMPOUND | Ospray, Ltd. | 2006-12-15 |
| K062166 | ENAMEL PRO | Premier Dental Products Co. | 2006-11-21 |
| K042048 | GELATO PROPHYLAXIS PASTE | Deepak Products, Inc. | 2004-10-26 |
| K042200 | MI PASTE | GC America, Inc. | 2004-10-20 |
| K041371 | BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN | Novamin Technology, Inc. | 2004-08-23 |
| K040988 | ZIRCON-F PROPHYLAXIS PASTE | Pascal Co., Inc. | 2004-07-07 |
| K033785 | PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE | Discus Dental, Inc. | 2004-06-18 |