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FDA 510(k)

ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL

K-Number: K913698 · 1991-10-09

ApplicantHeraeus Kulzer, Inc.
Decision Date1991-10-09
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1991-10-09 under 510(k) number K913698. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL?

ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL is a medical device that received FDA 510(k) clearance on 1991-10-09. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K913698.

When did ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL receive FDA 510(k) clearance?

ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL received FDA 510(k) clearance on 1991-10-09, under 510(k) number K913698.

Who is the listed applicant for ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL?

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

What is the FDA product code for ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL?

The FDA product code for ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL is EBI.

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Other records listing Heraeus Kulzer, Inc. as applicant

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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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