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FDA 510(k)

PREMIER DIE-TRAK ARTICULATOR

K-Number: K884418 · 1988-11-14

ApplicantPremier Medical
Decision Date1988-11-14
Product CodeEJP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREMIER DIE-TRAK ARTICULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Premier Medical. It received FDA 510(k) clearance on 1988-11-14 under 510(k) number K884418. The device is classified under product code EJP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIER DIE-TRAK ARTICULATOR?

PREMIER DIE-TRAK ARTICULATOR is a medical device that received FDA 510(k) clearance on 1988-11-14. The listed applicant is Premier Medical. The 510(k) number is K884418.

When did PREMIER DIE-TRAK ARTICULATOR receive FDA 510(k) clearance?

PREMIER DIE-TRAK ARTICULATOR received FDA 510(k) clearance on 1988-11-14, under 510(k) number K884418.

Who is the listed applicant for PREMIER DIE-TRAK ARTICULATOR?

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

What is the FDA product code for PREMIER DIE-TRAK ARTICULATOR?

The FDA product code for PREMIER DIE-TRAK ARTICULATOR is EJP.

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 Premier Medical 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.

K896303BIOPSY PUNCHK894050MODIFIED DECANNULATION STOPPER

Related Devices (Code: EJP)

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.

K926190ALRAND INC. (DENTAL HAND INSTRUMENTS)Alrand, Inc.K896131GNATHOMAT ARTICULATORIvoclar North America, Inc.K892373DENTAL PLASTIC BITE FORKTexapol Corp.K872943DISPOSABLE ARTICULATORDentsply Intl.K863009GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEXSds Dental, Inc.K854702PLASTIC MOUNTING RINGSAlmore Intl., 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.

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