Dental Stain Remover
FDA 510(k) K761352 · Concept, Inc.
510(k) numberK761352
Submission
- Device name
- Dental Stain Remover
- Applicant
- Concept, Inc.
Mchenry, IL, US - Received
- December 28, 1976
- Decision date
- January 3, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K000290 | Lazersmile, LazerwhiteEFW · Traditional | Biolase Technology, Inc. | 04/14/2000SE |
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| K980995 | Plaq-Ataq-IEFW · Traditional | Ethicare | 08/20/1998SE |
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Questions and answers
When was Dental Stain Remover cleared by the FDA?
Dental Stain Remover (K761352) received a 510(k) decision of Substantially Equivalent on January 3, 1977, 6 days after the submission was received.
What is the product code of K761352?
The FDA product code is EFW – Toothbrush, Manual, a Class I (low risk) device regulated under 21 CFR 872.6855.