Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AMORPHOUS DIAMOND COATED SCREW

K-Number: K992538 · 1999-11-23

ApplicantNobel Biocare Uas, Inc.
Decision Date1999-11-23
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AMORPHOUS DIAMOND COATED SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare Uas, Inc.. It received FDA 510(k) clearance on 1999-11-23 under 510(k) number K992538. 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 AMORPHOUS DIAMOND COATED SCREW?

AMORPHOUS DIAMOND COATED SCREW is a medical device that received FDA 510(k) clearance on 1999-11-23. The listed applicant is Nobel Biocare Uas, Inc.. The 510(k) number is K992538.

When did AMORPHOUS DIAMOND COATED SCREW receive FDA 510(k) clearance?

AMORPHOUS DIAMOND COATED SCREW received FDA 510(k) clearance on 1999-11-23, under 510(k) number K992538.

Who is the listed applicant for AMORPHOUS DIAMOND COATED SCREW?

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

What is the FDA product code for AMORPHOUS DIAMOND COATED SCREW?

The FDA product code for AMORPHOUS DIAMOND COATED 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 Nobel Biocare Uas, 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.

K050444NOBELREPLACE ADAPTER, MODEL 32412K042658PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004K041661NOBEL BIOCARE ENDOSSEOUS IMPLANTSK041876NOBELDIRECT OD IMPLANTK041312NOBELRONDO DENTAL CERAMIC-ALUMINAK041275PROCERA ABUTMENT OCTAGON

View all 31 devices →

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.

↑