Trubyte Denture Cleanser/Polishing Compound
FDA 510(k) K000996 · Dentsply Intl.
510(k) numberK000996
Submission
- Device name
- Trubyte Denture Cleanser/Polishing Compound
- Applicant
- Dentsply Intl.
York, PA, US - Received
- March 28, 2000
- Decision date
- June 16, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
| 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 |
| K903686 | Argilite 4 Gold Alloy for PorcelainEFT · Traditional | Argen Precious Metals, Inc. | 08/29/1990SE |
| K895345 | Orad Toothbrush CleanerEFT · Traditional | Orad, Inc. | 03/07/1990SE |
| K890043 | Dentclean Concentrated Denture CleanserEFT · Traditional | K-P Co. | 06/07/1989SE |
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| K103244 | Qmix 2IN1 Endodontic Irrigating SolutionKJJ · Traditional | 02/14/2011SE |
| K093221 | Pre-Cemented Orthodontic Bracket System Extension IIDYH · Special | 10/30/2009SE |
| K083805 | Ankylos C/X Dental Implant SystemDZE · Traditional | 05/22/2009SE |
| K082198 | Durashield PlusLBH · Traditional | 10/29/2008SE |
| K072730 | Friadent Cercon and Ankylos Cercon Balance AbutmentsNHA · Traditional | 03/27/2008SE |
| K072989 | Axis SystemEFB · Traditional | 01/28/2008SE |
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Questions and answers
When was Trubyte Denture Cleanser/Polishing Compound cleared by the FDA?
Trubyte Denture Cleanser/Polishing Compound (K000996) received a 510(k) decision of Substantially Equivalent on June 16, 2000, 80 days after the submission was received.
What is the product code of K000996?
The FDA product code is EFT – Cleanser, Denture, Over The Counter, a Class I (low risk) device regulated under 21 CFR 872.3520.