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FDA 510(k)

SAFETY STOP NECKSTRAP

K-Number: K780814 · 1978-06-30

ApplicantNorthwest Orthodontics, Inc.
Decision Date1978-06-30
Product CodeDYT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SAFETY STOP NECKSTRAP is the device name listed in this FDA 510(k) record. The listed applicant is Northwest Orthodontics, Inc.. It received FDA 510(k) clearance on 1978-06-30 under 510(k) number K780814. The device is classified under product code DYT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFETY STOP NECKSTRAP?

SAFETY STOP NECKSTRAP is a medical device that received FDA 510(k) clearance on 1978-06-30. The listed applicant is Northwest Orthodontics, Inc.. The 510(k) number is K780814.

When did SAFETY STOP NECKSTRAP receive FDA 510(k) clearance?

SAFETY STOP NECKSTRAP received FDA 510(k) clearance on 1978-06-30, under 510(k) number K780814.

Who is the listed applicant for SAFETY STOP NECKSTRAP?

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

What is the FDA product code for SAFETY STOP NECKSTRAP?

The FDA product code for SAFETY STOP NECKSTRAP is DYT.

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 Northwest Orthodontics, 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.

K800748SNAP-WAY HEADGEARK790843SNAP-WAYK780747SNAP-WAYK771706SAIF-BOWK771095J HOOK HEADGEAR

Related Devices (Code: DYT)

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.

K935856DENTAURUM SPACE MAINTAINERDentauraum, Inc.K864376FIBERBONDDentec, Inc.K812239UNITEK PALATAL BARUnitek Corp.

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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