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FDA 510(k)

CONFORM

K-Number: K062157 · 2006-10-13

ApplicantApex Dental Materials, Inc.
Decision Date2006-10-13
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CONFORM 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 2006-10-13 under 510(k) number K062157. 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 CONFORM?

CONFORM is a medical device that received FDA 510(k) clearance on 2006-10-13. The listed applicant is Apex Dental Materials, Inc.. The 510(k) number is K062157.

When did CONFORM receive FDA 510(k) clearance?

CONFORM received FDA 510(k) clearance on 2006-10-13, under 510(k) number K062157.

Who is the listed applicant for CONFORM?

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 CONFORM?

The FDA product code for CONFORM is EBF.

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Other records listing Apex Dental Materials, 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.

K190998BA Pit & Fissure SealantK161077RnD TE and RnD SEK131043APEX UNIVERSAL ADHESIVEK131049ZRPK120620CLEAN AND BOOSTK110859METAL OPAQUER

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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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

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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