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)

ORTHO-JET CRYSTAL

K-Number: K112397 · 2011-11-04

ApplicantLang Dental Mfg. Co., Inc.
Decision Date2011-11-04
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHO-JET CRYSTAL is the device name listed in this FDA 510(k) record. The listed applicant is Lang Dental Mfg. Co., Inc.. It received FDA 510(k) clearance on 2011-11-04 under 510(k) number K112397. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO-JET CRYSTAL?

ORTHO-JET CRYSTAL is a medical device that received FDA 510(k) clearance on 2011-11-04. The listed applicant is Lang Dental Mfg. Co., Inc.. The 510(k) number is K112397.

When did ORTHO-JET CRYSTAL receive FDA 510(k) clearance?

ORTHO-JET CRYSTAL received FDA 510(k) clearance on 2011-11-04, under 510(k) number K112397.

Who is the listed applicant for ORTHO-JET CRYSTAL?

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

What is the FDA product code for ORTHO-JET CRYSTAL?

The FDA product code for ORTHO-JET CRYSTAL is EBI.

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 Lang Dental Mfg. Co., 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.

K100653JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MODK083195MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESINK081981LANG DENTAL ACRYLIC PRIMERK081514TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDERK081705LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESINK072580JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23

View all 9 devices →

Related Devices (Code: EBI)

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, 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.

↑