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FDA 510(k)

BELLEGLASS POINT 4

K-Number: K030646 · 2003-05-06

ApplicantKerr Dental Materials Center
Decision Date2003-05-06
Product CodeEBD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BELLEGLASS POINT 4 is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Dental Materials Center. It received FDA 510(k) clearance on 2003-05-06 under 510(k) number K030646. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BELLEGLASS POINT 4?

BELLEGLASS POINT 4 is a medical device that received FDA 510(k) clearance on 2003-05-06. The listed applicant is Kerr Dental Materials Center. The 510(k) number is K030646.

When did BELLEGLASS POINT 4 receive FDA 510(k) clearance?

BELLEGLASS POINT 4 received FDA 510(k) clearance on 2003-05-06, under 510(k) number K030646.

Who is the listed applicant for BELLEGLASS POINT 4?

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

What is the FDA product code for BELLEGLASS POINT 4?

The FDA product code for BELLEGLASS POINT 4 is EBD.

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Other records listing Kerr Dental Materials Center as applicant

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Related Devices (Code: EBD)

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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