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FDA 510(k)

SURPASS

K-Number: K061981 · 2006-07-31

ApplicantApex Dental Materials, Inc.
Decision Date2006-07-31
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SURPASS 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 2006-07-31 under 510(k) number K061981. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURPASS?

SURPASS is a medical device that received FDA 510(k) clearance on 2006-07-31. The listed applicant is Apex Dental Materials, Inc.. The 510(k) number is K061981.

When did SURPASS receive FDA 510(k) clearance?

SURPASS received FDA 510(k) clearance on 2006-07-31, under 510(k) number K061981.

Who is the listed applicant for SURPASS?

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 SURPASS?

The FDA product code for SURPASS is KLE.

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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: KLE)

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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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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