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FDA 510(k)

DENTAURUM EXPANSION SCREWS

K-Number: K935154 · 1994-02-03

ApplicantDentauraum, Inc.
Decision Date1994-02-03
Product CodeDYJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAURUM EXPANSION SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Dentauraum, Inc.. It received FDA 510(k) clearance on 1994-02-03 under 510(k) number K935154. The device is classified under product code DYJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAURUM EXPANSION SCREWS?

DENTAURUM EXPANSION SCREWS is a medical device that received FDA 510(k) clearance on 1994-02-03. The listed applicant is Dentauraum, Inc.. The 510(k) number is K935154.

When did DENTAURUM EXPANSION SCREWS receive FDA 510(k) clearance?

DENTAURUM EXPANSION SCREWS received FDA 510(k) clearance on 1994-02-03, under 510(k) number K935154.

Who is the listed applicant for DENTAURUM EXPANSION SCREWS?

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 EXPANSION SCREWS?

The FDA product code for DENTAURUM EXPANSION SCREWS is DYJ.

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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 CDK952868DENTAURUM JACKET CROWN & ROOT POSTSK942667DENT-O-CRYL ORTHODONTIC ACRYLIC

View all 24 devices →

Related Devices (Code: DYJ)

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.

K970930BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCECleft Palate Appliances, Inc.K925088EXPANSION SCREWSForestadentK912417MOLAR DISTALIZING ASSEMBLYAmerican OrthodonticsK843705MANDIBULATOR JAW POSITIONERA Company, 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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