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FDA 510(k)

VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE

K-Number: K010544 · 2001-08-10

ApplicantApex Dental Materials, Inc.
Decision Date2001-08-10
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE is the device name listed in this FDA 510(k) record. The listed applicant is Apex Dental Materials, Inc.. It received FDA 510(k) clearance on 2001-08-10 under 510(k) number K010544. 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 VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE?

VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE is a medical device that received FDA 510(k) clearance on 2001-08-10. The listed applicant is Apex Dental Materials, Inc.. The 510(k) number is K010544.

When did VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE receive FDA 510(k) clearance?

VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE received FDA 510(k) clearance on 2001-08-10, under 510(k) number K010544.

Who is the listed applicant for VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE?

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

What is the FDA product code for VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE?

The FDA product code for VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE is DYH.

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Other records listing Apex Dental Materials, Inc. as applicant

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Related Devices (Code: DYH)

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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