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FDA 510(k)

SILANE

K-Number: K896659 · 1990-02-14

ApplicantPulpdent Corp.
Decision Date1990-02-14
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SILANE is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corp.. It received FDA 510(k) clearance on 1990-02-14 under 510(k) number K896659. 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 SILANE?

SILANE is a medical device that received FDA 510(k) clearance on 1990-02-14. The listed applicant is Pulpdent Corp.. The 510(k) number is K896659.

When did SILANE receive FDA 510(k) clearance?

SILANE received FDA 510(k) clearance on 1990-02-14, under 510(k) number K896659.

Who is the listed applicant for SILANE?

The FDA 510(k) record lists Pulpdent Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILANE?

The FDA product code for SILANE is KLE.

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Other records listing Pulpdent Corp. 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.

K014138PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENTK014133PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVEK020115PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEMK014059PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVEK013411PULPDENT CAVITY PREPARATION IVK994180PULPDENT CAVITY PREPARATION III

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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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