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)

PEMACO BITE WAX SHEETS

K-Number: K895563 · 1989-11-06

ApplicantPemaco, Inc.
Decision Date1989-11-06
Product CodeEGD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PEMACO BITE WAX SHEETS is the device name listed in this FDA 510(k) record. The listed applicant is Pemaco, Inc.. It received FDA 510(k) clearance on 1989-11-06 under 510(k) number K895563. The device is classified under product code EGD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEMACO BITE WAX SHEETS?

PEMACO BITE WAX SHEETS is a medical device that received FDA 510(k) clearance on 1989-11-06. The listed applicant is Pemaco, Inc.. The 510(k) number is K895563.

When did PEMACO BITE WAX SHEETS receive FDA 510(k) clearance?

PEMACO BITE WAX SHEETS received FDA 510(k) clearance on 1989-11-06, under 510(k) number K895563.

Who is the listed applicant for PEMACO BITE WAX SHEETS?

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

What is the FDA product code for PEMACO BITE WAX SHEETS?

The FDA product code for PEMACO BITE WAX SHEETS is EGD.

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 Pemaco, 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.

K910676INTRAORAL DENTAL WAXK895562PEMACO 2000 INTRAORAL DENTAL WAXK895566PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFTK895564PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARDK895561PEMACO 3000 INTRAORAL DENTAL WAXK895565PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD

View all 7 devices →

Related Devices (Code: EGD)

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.

K020009BRACE EZEUdent, Inc.K945535GLENROE ORTHO-SILGlenroe TechnologiesK924024ORTHO WAXHeraeus Kulzer, Inc.K923586BURNOUT MATERIALDentsply Intl.K914892SALIVA-STIMOrion Diagnostica, Inc.K922380BITE RIM WAXDentsply Intl.

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.

↑