PVS Dual Cure Veneer Bonding Kit
FDA 510(k) K894391 · Jelenko Co.
510(k) numberK894391
Submission
- Device name
- PVS Dual Cure Veneer Bonding Kit
- Applicant
- Jelenko Co.
Armonk, NY, US - Received
- July 17, 1989
- Decision date
- September 19, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was PVS Dual Cure Veneer Bonding Kit cleared by the FDA?
PVS Dual Cure Veneer Bonding Kit (K894391) received a 510(k) decision of Substantially Equivalent on September 19, 1989, 64 days after the submission was received.
What is the product code of K894391?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.