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FDA 510(k)

PLASTIC TOOTH REINFORCEMENT KIT

K-Number: K895758 · 1989-12-20

ApplicantNanzee Dental Products
Decision Date1989-12-20
Product CodeEBL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PLASTIC TOOTH REINFORCEMENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Nanzee Dental Products. It received FDA 510(k) clearance on 1989-12-20 under 510(k) number K895758. The device is classified under product code EBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLASTIC TOOTH REINFORCEMENT KIT?

PLASTIC TOOTH REINFORCEMENT KIT is a medical device that received FDA 510(k) clearance on 1989-12-20. The listed applicant is Nanzee Dental Products. The 510(k) number is K895758.

When did PLASTIC TOOTH REINFORCEMENT KIT receive FDA 510(k) clearance?

PLASTIC TOOTH REINFORCEMENT KIT received FDA 510(k) clearance on 1989-12-20, under 510(k) number K895758.

Who is the listed applicant for PLASTIC TOOTH REINFORCEMENT KIT?

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

What is the FDA product code for PLASTIC TOOTH REINFORCEMENT KIT?

The FDA product code for PLASTIC TOOTH REINFORCEMENT KIT is EBL.

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Related Devices (Code: EBL)

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.

K002693CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS)Cbs Intl. B.V.K952868DENTAURUM JACKET CROWN & ROOT POSTSDentauraum, Inc.K924376ROOT CANAL POSTThe Thera GroupK895283PROSTHETIC RESTORATION DEVICESwiss Precision Mfg. Corp.K883074ELGILOYDale T. DupuisK863831VIVADENT FILPINVivadent (Usa), Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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