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FDA 510(k)

DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT

K-Number: K032195 · 2003-10-07

ApplicantDentaurum
Decision Date2003-10-07
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Dentaurum. It received FDA 510(k) clearance on 2003-10-07 under 510(k) number K032195. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT?

DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT is a medical device that received FDA 510(k) clearance on 2003-10-07. The listed applicant is Dentaurum. The 510(k) number is K032195.

When did DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT receive FDA 510(k) clearance?

DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT received FDA 510(k) clearance on 2003-10-07, under 510(k) number K032195.

Who is the listed applicant for DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT?

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

What is the FDA product code for DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT?

The FDA product code for DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT is DYH.

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Other records listing Dentaurum 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.

K062733TOMAS PIN SD 6, 8, AND 10 MMK062732TOMAS PIN 6 MMK030644CONTEC DUO, CONTEC LC, CONTEC LCRK030977DENTAURUM MIX TWO-PASTE BRACKET ADHESIVEK030980DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVEK030641CONTEC LIGHT

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Related Devices (Code: DYH)

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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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