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FDA 510(k)

DENTAURUM JACKET CROWN & ROOT POSTS

K-Number: K952868 · 1995-07-19

ApplicantDentauraum, Inc.
Decision Date1995-07-19
Product CodeEBL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAURUM JACKET CROWN & ROOT POSTS is the device name listed in this FDA 510(k) record. The listed applicant is Dentauraum, Inc.. It received FDA 510(k) clearance on 1995-07-19 under 510(k) number K952868. 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 DENTAURUM JACKET CROWN & ROOT POSTS?

DENTAURUM JACKET CROWN & ROOT POSTS is a medical device that received FDA 510(k) clearance on 1995-07-19. The listed applicant is Dentauraum, Inc.. The 510(k) number is K952868.

When did DENTAURUM JACKET CROWN & ROOT POSTS receive FDA 510(k) clearance?

DENTAURUM JACKET CROWN & ROOT POSTS received FDA 510(k) clearance on 1995-07-19, under 510(k) number K952868.

Who is the listed applicant for DENTAURUM JACKET CROWN & ROOT POSTS?

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

What is the FDA product code for DENTAURUM JACKET CROWN & ROOT POSTS?

The FDA product code for DENTAURUM JACKET CROWN & ROOT POSTS is EBL.

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Other records listing Dentauraum, 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.

K952867REMANIUM:GM 700, GM 380, GM 800, GFHK952866REMATITAN TITANIUMK952870REMANIUM: CS & G-SOFTK952865REMANIUM: 200,CS, 380, AND CDK942667DENT-O-CRYL ORTHODONTIC ACRYLICK942666ORTHALGENAT IMPRESSION MATERIAL

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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.K924376ROOT CANAL POSTThe Thera GroupK895283PROSTHETIC RESTORATION DEVICESwiss Precision Mfg. Corp.K895758PLASTIC TOOTH REINFORCEMENT KITNanzee Dental ProductsK883074ELGILOYDale T. DupuisK863831VIVADENT FILPINVivadent (Usa), Inc.

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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