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FDA 510(k)

MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN

K-Number: K083195 · 2009-06-05

ApplicantLang Dental Mfg. Co., Inc.
Decision Date2009-06-05
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN 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 2009-06-05 under 510(k) number K083195. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN?

MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN is a medical device that received FDA 510(k) clearance on 2009-06-05. The listed applicant is Lang Dental Mfg. Co., Inc.. The 510(k) number is K083195.

When did MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN receive FDA 510(k) clearance?

MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN received FDA 510(k) clearance on 2009-06-05, under 510(k) number K083195.

Who is the listed applicant for MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN?

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 MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN?

The FDA product code for MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN is EBG.

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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.

K112397ORTHO-JET CRYSTALK100653JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MODK081981LANG 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: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

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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