Adhesive Precoated Brackets
FDA 510(k) K911271 · Unitek Corp.
510(k) numberK911271
Submission
- Device name
- Adhesive Precoated Brackets
- Applicant
- Unitek Corp.
Monrovia, CA, US - Received
- March 22, 1991
- Decision date
- May 29, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K910288 | Nonstaining AlastiksEJF · Traditional | 03/29/1991SE |
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Questions and answers
When was Adhesive Precoated Brackets cleared by the FDA?
Adhesive Precoated Brackets (K911271) received a 510(k) decision of Substantially Equivalent on May 29, 1991, 68 days after the submission was received.
What is the product code of K911271?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.