Enlight (Tentative Name)
FDA 510(k) K972890 · Sybron Dental Specialties, Inc.
510(k) numberK972890
Submission
- Device name
- Enlight (Tentative Name)
- Applicant
- Sybron Dental Specialties, Inc.
Orange, CA, US - Received
- August 5, 1997
- Decision date
- September 16, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesKIF · Special | 04/14/2016SE |
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Questions and answers
When was Enlight (Tentative Name) cleared by the FDA?
Enlight (Tentative Name) (K972890) received a 510(k) decision of Substantially Equivalent on September 16, 1997, 42 days after the submission was received.
What is the product code of K972890?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.