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FDA 510(k)

SPEEDY ORTHODONTIC SCREW

K-Number: K060500 · 2006-06-16

ApplicantDentium Co., Ltd.
Decision Date2006-06-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPEEDY ORTHODONTIC SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Dentium Co., Ltd.. It received FDA 510(k) clearance on 2006-06-16 under 510(k) number K060500. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPEEDY ORTHODONTIC SCREW?

SPEEDY ORTHODONTIC SCREW is a medical device that received FDA 510(k) clearance on 2006-06-16. The listed applicant is Dentium Co., Ltd.. The 510(k) number is K060500.

When did SPEEDY ORTHODONTIC SCREW receive FDA 510(k) clearance?

SPEEDY ORTHODONTIC SCREW received FDA 510(k) clearance on 2006-06-16, under 510(k) number K060500.

Who is the listed applicant for SPEEDY ORTHODONTIC SCREW?

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

What is the FDA product code for SPEEDY ORTHODONTIC SCREW?

The FDA product code for SPEEDY ORTHODONTIC SCREW is DZE.

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Other records listing Dentium Co., Ltd. as applicant

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Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, 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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