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FDA 510(k)

SDI POLYCARBONATE CROWN, SCHEIN'S

K-Number: K892893 · 1989-06-06

ApplicantSvenska Dental Instruments AB
Decision Date1989-06-06
Product CodeELZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SDI POLYCARBONATE CROWN, SCHEIN'S is the device name listed in this FDA 510(k) record. The listed applicant is Svenska Dental Instruments AB. It received FDA 510(k) clearance on 1989-06-06 under 510(k) number K892893. The device is classified under product code ELZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SDI POLYCARBONATE CROWN, SCHEIN'S?

SDI POLYCARBONATE CROWN, SCHEIN'S is a medical device that received FDA 510(k) clearance on 1989-06-06. The listed applicant is Svenska Dental Instruments AB. The 510(k) number is K892893.

When did SDI POLYCARBONATE CROWN, SCHEIN'S receive FDA 510(k) clearance?

SDI POLYCARBONATE CROWN, SCHEIN'S received FDA 510(k) clearance on 1989-06-06, under 510(k) number K892893.

Who is the listed applicant for SDI POLYCARBONATE CROWN, SCHEIN'S?

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

What is the FDA product code for SDI POLYCARBONATE CROWN, SCHEIN'S?

The FDA product code for SDI POLYCARBONATE CROWN, SCHEIN'S is ELZ.

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 Svenska Dental Instruments AB 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.

K022264CLEAN 'N' OILK022265LIGHT TIPK892894S-FILE, S-FINDER, S-ENGINE FILE

Related Devices (Code: ELZ)

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.

K091362CERAMIC PEDATRIC PREFORMED CROWNEz-Pedo, Inc.K932759TEMPOARY POLYCARBONATE CROWNSSouth American Dental Exporting Corp.K931352PEDO JACKETS OR PJ'SGeorge M. Wilson, DdsK913152WHITER BITER CROWNGeorge M. Wilson, DdsK912686WHITER BITER CROWNGeorge M. Wilson, DdsK883325PERFORMED CROWN (STAINLESS STEEL)Whitecap Dental Co.

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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