Oratec Dental Products
Country not established
- Devices
- 3
What Oratec Dental Products makes
Oratec Dental Products manufactures dental impression materials, including Triflex Silicone, and dental cement, such as Ultra-Bond. These products are designed for use in dental procedures requiring accurate molds and durable bonding agents.
The company’s portfolio is regulated under FDA 510(k) clearance as Class II medical devices. The products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Impression Material, Triflex Silicone Ref K760240
Regimes: 510(k) Registry: 510(k)Impression Material, Triflex Silicone Ref K760238
Regimes: 510(k) Registry: 510(k)Cement, Ultra-Bond Ref K760239
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Oratec Dental Products have in the registry?
The registry currently lists 3 devices for Oratec Dental Products. Devices recorded under merged duplicate company entries are counted once.
Which registries list Oratec Dental Products's devices?
Among its 3 most recently registered devices, Oratec Dental Products has devices listed in FDA 510(k) (3 devices).
What risk classes do Oratec Dental Products's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Oratec Dental Products's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Oratec Dental Products in the registry?
The most recently registered devices listed for Oratec Dental Products include IMPRESSION MATERIAL, TRIFLEX SILICONE and CEMENT, ULTRA-BOND.