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FDA 510(k)

HA-TI (HAND TITANIUM SCREW) IMPLANT

K-Number: K003045 · 2001-07-12

ApplicantHati Dental Ag.
Decision Date2001-07-12
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HA-TI (HAND TITANIUM SCREW) IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Hati Dental Ag.. It received FDA 510(k) clearance on 2001-07-12 under 510(k) number K003045. 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 HA-TI (HAND TITANIUM SCREW) IMPLANT?

HA-TI (HAND TITANIUM SCREW) IMPLANT is a medical device that received FDA 510(k) clearance on 2001-07-12. The listed applicant is Hati Dental Ag.. The 510(k) number is K003045.

When did HA-TI (HAND TITANIUM SCREW) IMPLANT receive FDA 510(k) clearance?

HA-TI (HAND TITANIUM SCREW) IMPLANT received FDA 510(k) clearance on 2001-07-12, under 510(k) number K003045.

Who is the listed applicant for HA-TI (HAND TITANIUM SCREW) IMPLANT?

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

What is the FDA product code for HA-TI (HAND TITANIUM SCREW) IMPLANT?

The FDA product code for HA-TI (HAND TITANIUM SCREW) IMPLANT is DZE.

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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

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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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