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FDA 510(k)

K-ETCHANT SYRINGE; NEEDLE TIP (E)

K-Number: K133078 · 2013-12-20

ApplicantKuraray Noritake Dental, Inc.
Decision Date2013-12-20
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

K-ETCHANT SYRINGE; NEEDLE TIP (E) is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K133078. 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 K-ETCHANT SYRINGE; NEEDLE TIP (E)?

K-ETCHANT SYRINGE; NEEDLE TIP (E) is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Kuraray Noritake Dental, Inc.. The 510(k) number is K133078.

When did K-ETCHANT SYRINGE; NEEDLE TIP (E) receive FDA 510(k) clearance?

K-ETCHANT SYRINGE; NEEDLE TIP (E) received FDA 510(k) clearance on 2013-12-20, under 510(k) number K133078.

Who is the listed applicant for K-ETCHANT SYRINGE; NEEDLE TIP (E)?

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

What is the FDA product code for K-ETCHANT SYRINGE; NEEDLE TIP (E)?

The FDA product code for K-ETCHANT SYRINGE; NEEDLE TIP (E) is KLE.

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Other records listing Kuraray Noritake Dental, Inc. as applicant

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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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