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FDA 510(k)

PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, INC.

K-Number: K933831 · 1993-12-06

ApplicantNu-Dent, Inc.
Decision Date1993-12-06
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, INC. is the device name listed in this FDA 510(k) record. The listed applicant is Nu-Dent, Inc.. It received FDA 510(k) clearance on 1993-12-06 under 510(k) number K933831. 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 PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, INC.?

PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, INC. is a medical device that received FDA 510(k) clearance on 1993-12-06. The listed applicant is Nu-Dent, Inc.. The 510(k) number is K933831.

When did PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, INC. receive FDA 510(k) clearance?

PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, INC. received FDA 510(k) clearance on 1993-12-06, under 510(k) number K933831.

Who is the listed applicant for PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, INC.?

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

What is the FDA product code for PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, INC.?

The FDA product code for PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, INC. is EBI.

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Related Devices (Code: EBI)

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.

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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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