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FDA 510(k)

KERALLOY NON-GAMMA 2 AMALGAM

K-Number: K912992 · 1991-11-13

ApplicantWilde-USA, Inc.
Decision Date1991-11-13
Product CodeEJJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KERALLOY NON-GAMMA 2 AMALGAM is the device name listed in this FDA 510(k) record. The listed applicant is Wilde-USA, Inc.. It received FDA 510(k) clearance on 1991-11-13 under 510(k) number K912992. The device is classified under product code EJJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KERALLOY NON-GAMMA 2 AMALGAM?

KERALLOY NON-GAMMA 2 AMALGAM is a medical device that received FDA 510(k) clearance on 1991-11-13. The listed applicant is Wilde-USA, Inc.. The 510(k) number is K912992.

When did KERALLOY NON-GAMMA 2 AMALGAM receive FDA 510(k) clearance?

KERALLOY NON-GAMMA 2 AMALGAM received FDA 510(k) clearance on 1991-11-13, under 510(k) number K912992.

Who is the listed applicant for KERALLOY NON-GAMMA 2 AMALGAM?

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

What is the FDA product code for KERALLOY NON-GAMMA 2 AMALGAM?

The FDA product code for KERALLOY NON-GAMMA 2 AMALGAM is EJJ.

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Other records listing Wilde-USA, 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.

K913582COMPATIT RK915653KERAMAILK913581WILDE ADHESIVE BONDING SYSTEMK923472COMPACOLORK920649COMPASEPK915250WIL-PDS & WIL-PDI CASTING ALLOYS

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Related Devices (Code: EJJ)

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.

K053114SILVERFILDunia Perwira Manufacturing Sdn. Bhd.K051010SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70SeptodontK033434BESTALOYWe Dong Myung Dental Industrial Co., Ltd.K032152BENCO ADMIXSouthern Dental Industries, Inc.K031658BENCO SPHERICALSouthern Dental Industries, Inc.K020452HIGH SILVER CONVENTIONALAb Ardent

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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