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FDA 510(k)

SOFT DENTURE RELINE MATERIAL ELASTOLINE

K-Number: K925275 · 1993-01-11

ApplicantGreat Lakes Orthodontics, Ltd.
Decision Date1993-01-11
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOFT DENTURE RELINE MATERIAL ELASTOLINE is the device name listed in this FDA 510(k) record. The listed applicant is Great Lakes Orthodontics, Ltd.. It received FDA 510(k) clearance on 1993-01-11 under 510(k) number K925275. 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 SOFT DENTURE RELINE MATERIAL ELASTOLINE?

SOFT DENTURE RELINE MATERIAL ELASTOLINE is a medical device that received FDA 510(k) clearance on 1993-01-11. The listed applicant is Great Lakes Orthodontics, Ltd.. The 510(k) number is K925275.

When did SOFT DENTURE RELINE MATERIAL ELASTOLINE receive FDA 510(k) clearance?

SOFT DENTURE RELINE MATERIAL ELASTOLINE received FDA 510(k) clearance on 1993-01-11, under 510(k) number K925275.

Who is the listed applicant for SOFT DENTURE RELINE MATERIAL ELASTOLINE?

The FDA 510(k) record lists Great Lakes Orthodontics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOFT DENTURE RELINE MATERIAL ELASTOLINE?

The FDA product code for SOFT DENTURE RELINE MATERIAL ELASTOLINE is EBI.

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Other records listing Great Lakes Orthodontics, Ltd. as applicant

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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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