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FDA 510(k)

FORMA Composite (Shade A3D)

K-Number: K240694 · 2024-03-15

ApplicantUltradent Products, Inc.
Decision Date2024-03-15
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FORMA Composite (Shade A3D) is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 2024-03-15 under 510(k) number K240694. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORMA Composite (Shade A3D)?

FORMA Composite (Shade A3D) is a medical device that received FDA 510(k) clearance on 2024-03-15. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K240694.

When did FORMA Composite (Shade A3D) receive FDA 510(k) clearance?

FORMA Composite (Shade A3D) received FDA 510(k) clearance on 2024-03-15, under 510(k) number K240694.

Who is the listed applicant for FORMA Composite (Shade A3D)?

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

What is the FDA product code for FORMA Composite (Shade A3D)?

The FDA product code for FORMA Composite (Shade A3D) is EBF.

Other records listing Ultradent Products, Inc. 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.

K262228Transcend Bulk Fill Flowable CompositeK261404UltraEZK240743Peak Universal BondK221909J-TempK220471VALO X, VALO X Accessory LensesK211905UltraCal XS

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Related Devices (Code: EBF)

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.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.

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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