510(k) K903686
- Device
- Argilite 4 Gold Alloy For Porcelain
- Applicant
- ARGEN PRECIOUS METALS, INC.
- 510(k) number
- K903686
- Product code
- EFT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-08-29
- Date received
- 1990-08-13
- Regulation
- 872.3520
- Classification name
- Cleanser, Denture, Over The Counter
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LAL MALHOTRA
- Address
- 8380 Miralani Dr. San Diego CA US 92126 92126
FDA Registration Numbers#
- 9617667
- 3027341451
- 3017248108
- 3008925277
- 3014624980
- 9617200
- 1036212
- 3011547262
- 3038718579
- 3029507159
- 1316408
- 3015128224
- 3007060769
- 1058743
- 3012118920
- 3005343641
- 8010414
- 3005628474
- 9614573
- 3045855232
- 3044819802
- 3005695824
- 3008770703
- 3022777869
- 3012764743
- 3009170513
- 3014314529
- 3004069780
- 3014579161
- 3030795695
- 3003887639
- 3013496867
- 3021624342
- 2087259
- 1719513
- 3015168527
- 3006186796
- 3013520830
- 3004122135
- 1821514
- 3023895623
- 3017609565
- 3011191255
- 3014268398
- 3008910197
- 3024555465
- 3008797926
- 1720499
- 2424472
- 1000415764
- 3013181914
- 3017268636
- 9616852
- 9616065
- 3011252807
- 3042752927
- 2081322
- 1911445
- 9615151
- 3005985361
- 3009336980
- 3003491259
- 3013528379
- 3012896103
- 3012117640
- 3025414363
- 3008485841
- 3012047097
- 3005598536
- 3021636076
- 3014545262
- 3006707038
- 3005558160
- 3011964664
- 3015379531
- 3009211643
- 9680216
- 3015414875
- 3009171220
- 3043303267
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EFT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K080631 | CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER | Oral Health Technologies, LLC | 2008-05-23 |
| 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 |
| 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 |