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FDA 510(k)

OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW

K-Number: K952634 · 1995-09-18

ApplicantOpti-Max
Decision Date1995-09-18
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Opti-Max. It received FDA 510(k) clearance on 1995-09-18 under 510(k) number K952634. 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 OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW?

OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW is a medical device that received FDA 510(k) clearance on 1995-09-18. The listed applicant is Opti-Max. The 510(k) number is K952634.

When did OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW receive FDA 510(k) clearance?

OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW received FDA 510(k) clearance on 1995-09-18, under 510(k) number K952634.

Who is the listed applicant for OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW?

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

What is the FDA product code for OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW?

The FDA product code for OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Opti-Max 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.

K972769OPTI-MAX ANGLED CROWN POST FOR EXTERNALLY-HEXED IMPLANTS, IN 15 DEGREE AND 25 DEGREE INCLINATIONS. FOR IMPLANTS 3.3MM, 4K960022OPTI-MAX BODY DIAMETER W/5MM TOP W/EXTERNAL HEX, EXTERNALLY THREADED DENTAL IMPLANT COARSE THREADSK955332OPTI-MAX EXTERNALLY THREADED CYLINDRICAL INTERNAL BORE DENTAL IMPLANT, WITH HEALING SCREWK952592OPTI-MAX INTERNAL-HEX ANGLED IMPLANT CROWN POST, 10 DEGREE & 20 DEGREE INCLINATIONSK944943OPTI-MAX PRESS-FIT EXTERNAL-HEX DENTAL

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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