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FDA 510(k)

EXPANSION SCREWS

K-Number: K925088 · 1993-05-22

ApplicantForestadent
Decision Date1993-05-22
Product CodeDYJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EXPANSION SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Forestadent. It received FDA 510(k) clearance on 1993-05-22 under 510(k) number K925088. 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 EXPANSION SCREWS?

EXPANSION SCREWS is a medical device that received FDA 510(k) clearance on 1993-05-22. The listed applicant is Forestadent. The 510(k) number is K925088.

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

EXPANSION SCREWS received FDA 510(k) clearance on 1993-05-22, under 510(k) number K925088.

Who is the listed applicant for EXPANSION SCREWS?

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

What is the FDA product code for EXPANSION SCREWS?

The FDA product code for EXPANSION SCREWS is DYJ.

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 Forestadent 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.

K925028FORESTADENT ORTHODONTIC BANDS

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.K935154DENTAURUM EXPANSION SCREWSDentauraum, Inc.K912417MOLAR DISTALIZING ASSEMBLYAmerican OrthodonticsK843705MANDIBULATOR JAW POSITIONERA Company, 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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