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FDA 510(k)

PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT

K-Number: K860653 · 1986-04-17

ApplicantOtc/America
Decision Date1986-04-17
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Otc/America. It received FDA 510(k) clearance on 1986-04-17 under 510(k) number K860653. 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 PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT?

PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 1986-04-17. The listed applicant is Otc/America. The 510(k) number is K860653.

When did PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT receive FDA 510(k) clearance?

PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT received FDA 510(k) clearance on 1986-04-17, under 510(k) number K860653.

Who is the listed applicant for PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT?

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

What is the FDA product code for PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT?

The FDA product code for PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT is DZE.

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 Otc/America 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.

K862110OSSEODENT DRILLING SYSTEM

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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