Willi Geller Creation Porcelain

FDA 510(k)

Class II (US FDA 510(k))

510(k) K981490

Identifiers

510(k) Number: K981490 FDA 510(k)
FDA Product Code: EIH FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 872.6660 FDA 510(k)
Regulation Number: 872.6660 FDA 510(k)
Advisory Committee: Dental FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The WILLI GELLER CREATION PORCELAIN device is a traditional dental powder product that has been deemed substantially equivalent to existing standards. Developed by Jensen Industries, Inc., this powder features [list key features here]. As a result of its successful review process, it was granted clearance under the US regulation 872.6660. For more information on its regulatory compliance and market status, please refer to the decision description provided.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K981490	Class II	Active

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Manufacturer

Manufacturer: Jensen Industries, Inc.

Sources (1)

FDA 510(k) K981490 24 fields · synced Jul 25, 2026