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FDA 510(k)

ANTERIOR & POST. RESTORATIVE PASTE SYS.

K-Number: K800389 · 1980-04-10

ApplicantAmerican Dental Research
Decision Date1980-04-10
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ANTERIOR & POST. RESTORATIVE PASTE SYS. is the device name listed in this FDA 510(k) record. The listed applicant is American Dental Research. It received FDA 510(k) clearance on 1980-04-10 under 510(k) number K800389. 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 ANTERIOR & POST. RESTORATIVE PASTE SYS.?

ANTERIOR & POST. RESTORATIVE PASTE SYS. is a medical device that received FDA 510(k) clearance on 1980-04-10. The listed applicant is American Dental Research. The 510(k) number is K800389.

When did ANTERIOR & POST. RESTORATIVE PASTE SYS. receive FDA 510(k) clearance?

ANTERIOR & POST. RESTORATIVE PASTE SYS. received FDA 510(k) clearance on 1980-04-10, under 510(k) number K800389.

Who is the listed applicant for ANTERIOR & POST. RESTORATIVE PASTE SYS.?

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

What is the FDA product code for ANTERIOR & POST. RESTORATIVE PASTE SYS.?

The FDA product code for ANTERIOR & POST. RESTORATIVE PASTE SYS. is KLE.

Related Clinical Trials

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.

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Other records listing American Dental Research 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.

K800391PAINT-ON-RESTORATIVE W/FISSURE SEALERK800390ANT. & POST. RESTORATIVE POWDER LIQ.K800393POLY SULFIDE IMPRESSION PASTE W/CATALYSTK800392BRACKET BONDING SYSTEM METAL & PLASTIC

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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