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FDA 510(k)

ADHESIVE 1

K-Number: K050331 · 2005-03-24

ApplicantSouthern Dental Industries, Inc.
Decision Date2005-03-24
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ADHESIVE 1 is the device name listed in this FDA 510(k) record. The listed applicant is Southern Dental Industries, Inc.. It received FDA 510(k) clearance on 2005-03-24 under 510(k) number K050331. 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 ADHESIVE 1?

ADHESIVE 1 is a medical device that received FDA 510(k) clearance on 2005-03-24. The listed applicant is Southern Dental Industries, Inc.. The 510(k) number is K050331.

When did ADHESIVE 1 receive FDA 510(k) clearance?

ADHESIVE 1 received FDA 510(k) clearance on 2005-03-24, under 510(k) number K050331.

Who is the listed applicant for ADHESIVE 1?

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

What is the FDA product code for ADHESIVE 1?

The FDA product code for ADHESIVE 1 is KLE.

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Other records listing Southern Dental Industries, 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.

K062065RIVA LUTING PLUSK062064RIVA BOND LCK050871RIVA PROTECTK050870RIVA LIGHT CUREK042452RIVA SILVERK040393RIVA LUTING

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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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