510(k) K080631
- Device
- CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER
- Applicant
- ORAL HEALTH TECHNOLOGIES, LLC
- 510(k) number
- K080631
- Product code
- EFT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-05-23
- Date received
- 2008-03-05
- Regulation
- 872.3520
- Classification name
- Cleanser, Denture, Over The Counter
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT E TRICCA
- Address
- 1062 Allegheny Dr. Danville CA US 94526 94526
FDA Registration Numbers#
- 3012293198
- 2081322
- 3015946389
- 3012764743
- 3011774865
- 3009336980
- 3013528379
- 3007527669
- 3043303267
- 3008485841
- 3009171220
- 3033615362
- 9616852
- 3038718579
- 3007060769
- 3008808082
- 3015379531
- 3014468707
- 3004134939
- 3004597845
- 1719513
- 3024555465
- 3027320022
- 3011283823
- 3044819802
- 3013600135
- 2424472
- 3012084431
- 3014624980
- 3005558160
- 3021624342
- 3015128224
- 3011547262
- 3012118920
- 3004122135
- 3031978013
- 3008346537
- 3010583458
- 3008925277
- 1821514
- 9617667
- 2029234
- 3003887639
- 3012041047
- 3005628474
- 1316408
- 3042277637
- 9614573
- 2529851
- 3017022128
- 8020152
- 3005343641
- 3045855232
- 9615151
- 2435946
- 3005985361
- 1000415764
- 1210513
- 3013496867
- 3005596071
- 3027341451
- 3015168527
- 2518467
- 3013520830
- 3011191255
- 3017609565
- 3006707038
- 8010414
- 9680216
- 3011252807
- 3012421607
- 3016447764
- 3021636076
- 3023895623
- 3009170513
- 3009937681
- 3014545262
- 3012896103
- 3005505603
- 1058743
Source Documents#
Other 510(k) Records For Product Code EFT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K051342 | MEDICAL INTERPOROUS | Bonyf AG | 2006-06-02 |
| K000996 | TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND | Dentsply Intl. | 2000-06-16 |
| K942203 | OTC DENTURE CLEANSER | Combe, Inc. | 1994-08-10 |
| K930337 | PROFAST(R)-DENTURE CLEANSER | Fittydent-Altwirth & Schmitt GmbH | 1993-09-07 |
| K914257 | DENTURE PRODUCT X | Essential Dental Systems, Inc. | 1993-01-13 |
| K925259 | CFR MONOGRAPH | Combe, Inc. | 1993-01-11 |
| K902838 | DENTURE DYNAMIC'S DENTURE MAGIC | Denture Dynamic'S, Inc. | 1990-09-06 |
| K903686 | ARGILITE 4 GOLD ALLOY FOR PORCELAIN | Argen Precious Metals, Inc. | 1990-08-29 |
| K895345 | ORAD TOOTHBRUSH CLEANER | Orad, Inc. | 1990-03-07 |
| K890043 | DENTCLEAN CONCENTRATED DENTURE CLEANSER | K-P Co. | 1989-06-07 |
| K890668 | CLEAN DENT | Lincoln Park Dental Laboratory | 1989-04-17 |
| K880068 | EFFERVESCENT DENTURE CLEANSER | Perrigo Co. | 1988-03-07 |
| K874805 | TATUNG'S DENTURE CLEANING SOLUTION | Tatung Company of America, Inc. | 1988-02-16 |
| K871785 | DENTURE CLEANSING TABLET | Pennex Products Co., Inc. | 1987-09-11 |
| K854995 | DENCLENZ | Creighton Products Corp. | 1986-05-12 |
Legacy Summary#
summary
FDA Review#
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