Argilite 4 Gold Alloy for Porcelain
FDA 510(k) K903686 · Argen Precious Metals, Inc.
510(k) numberK903686
Submission
- Device name
- Argilite 4 Gold Alloy for Porcelain
- Applicant
- Argen Precious Metals, Inc.
San Diego, CA, US - Received
- August 13, 1990
- Decision date
- August 29, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EFT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K080631 | Cleanse.Freshen.Go; Aligner Cleansing Towelette and Dental Appliance CleanserEFT · Traditional | Oral Health Technologies, LLC | 05/23/2008SE |
| K051342 | Medical InterporousEFT · Traditional | Bonyf AG | 06/02/2006SE |
| K000996 | Trubyte Denture Cleanser/Polishing CompoundEFT · Traditional | Dentsply Intl. | 06/16/2000SE |
| K942203 | OTC Denture CleanserEFT · Traditional | Combe, Inc. | 08/10/1994SE |
| K930337 | Profast(R)-Denture CleanserEFT · Traditional | Fittydent-Altwirth & Schmitt GmbH | 09/07/1993SE |
| K914257 | Denture Product XEFT · Traditional | Essential Dental Systems, Inc. | 01/13/1993SE |
| K925259 | CFR MonographEFT · Traditional | Combe, Inc. | 01/11/1993SE |
| K902838 | Denture Dynamic's Denture MagicEFT · Traditional | Denture Dynamic'S, Inc. | 09/06/1990SE |
| K895345 | Orad Toothbrush CleanerEFT · Traditional | Orad, Inc. | 03/07/1990SE |
| K890043 | Dentclean Concentrated Denture CleanserEFT · Traditional | K-P Co. | 06/07/1989SE |
More from K-P Co.
| 510(k) | Device | Decision |
|---|---|---|
| K965216 | Argi-Satin or OPTI0-STARELL · Traditional | 02/27/1997SE |
| K961352 | 285 SLEJT · Traditional | 05/20/1996SE |
| K961211 | Argelite 52+EJT · Traditional | 04/25/1996SE |
| K961285 | Argedent 40(GOLD-PALLADIUM-SILVER Alloy for Porcelain Application)EJT · Traditional | 04/18/1996SE |
| K954362 | Argistar 74EJT · Traditional | 10/12/1995SE |
| K954404 | Aurolite 45EJT · Traditional | 10/07/1995SE |
| K954371 | Surefire SEJT · Traditional | 10/07/1995SE |
| K954368 | Argedent Bio 87 PFEJT · Traditional | 10/07/1995SE |
| K954367 | Argistar Bio 75PFEJT · Traditional | 10/07/1995SE |
| K954361 | Argenco 68MEJT · Traditional | 10/07/1995SE |
Questions and answers
When was Argilite 4 Gold Alloy for Porcelain cleared by the FDA?
Argilite 4 Gold Alloy for Porcelain (K903686) received a 510(k) decision of Substantially Equivalent on August 29, 1990, 16 days after the submission was received.
What is the product code of K903686?
The FDA product code is EFT – Cleanser, Denture, Over The Counter, a Class I (low risk) device regulated under 21 CFR 872.3520.