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FDA 510(k)

WILLI GELLER CREAPEARL

K-Number: K010160 · 2001-03-27

ApplicantJensen Industries, Inc.
Decision Date2001-03-27
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

WILLI GELLER CREAPEARL is the device name listed in this FDA 510(k) record. The listed applicant is Jensen Industries, Inc.. It received FDA 510(k) clearance on 2001-03-27 under 510(k) number K010160. The device is classified under product code ELM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WILLI GELLER CREAPEARL?

WILLI GELLER CREAPEARL is a medical device that received FDA 510(k) clearance on 2001-03-27. The listed applicant is Jensen Industries, Inc.. The 510(k) number is K010160.

When did WILLI GELLER CREAPEARL receive FDA 510(k) clearance?

WILLI GELLER CREAPEARL received FDA 510(k) clearance on 2001-03-27, under 510(k) number K010160.

Who is the listed applicant for WILLI GELLER CREAPEARL?

The FDA 510(k) record lists Jensen Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WILLI GELLER CREAPEARL?

The FDA product code for WILLI GELLER CREAPEARL is ELM.

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Other records listing Jensen Industries, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183408Jensen Shade Effect LiquidsK112806JENSEN ZIRCONIAK111743THE INSYNC CERAMIC SYSTEMK070114CREATION CP-ZI PORCELAINK050838THE LF-P CERAMIC SYSTEMK043201WILLI GELLER CREATION ZI PORCELAIN

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Related Devices (Code: ELM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K122955DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUMWright Health Group , Ltd.K122925NEW STETIC ARTIFICIAL TEETHNew SteticK122852PHYSIOSTAR NFCCandulor USA, Inc.K121749VERACIAShofu Dental CorporationK120404MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHMerz Dental GmbHK120736SR PHONARES IIIvoclar Vivadent, AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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