Veneer System, Mostique Laminate
FDA 510(k) K782080 · Caulk Co., Div. Dentsply
510(k) numberK782080
Submission
- Device name
- Veneer System, Mostique Laminate
- Applicant
- Caulk Co., Div. Dentsply
Mchenry, IL, US - Received
- December 13, 1978
- Decision date
- January 26, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K260485 | Any-EtchKLE · Traditional | Mediclus Co., Ltd. | 05/14/2026SE |
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| K252469 | Magnabond Se; Magnabond Universal; Magnabond Universal DcaKLE · Traditional | Dmp Dental Industry S.A. | 11/06/2025SE |
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| K242530 | HF-Etchant Hydrofluoric Acid Etching GelKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 12/20/2024SE |
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Questions and answers
When was Veneer System, Mostique Laminate cleared by the FDA?
Veneer System, Mostique Laminate (K782080) received a 510(k) decision of Substantially Equivalent on January 26, 1979, 44 days after the submission was received.
What is the product code of K782080?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.