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FDA 510(k)

ORTHO-JET ACRYLIC RESIN - SPARKLE

K-Number: K941925 · 1994-05-27

ApplicantLang Dental Mfg. Co., Inc.
Decision Date1994-05-27
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHO-JET ACRYLIC RESIN - SPARKLE 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 1994-05-27 under 510(k) number K941925. 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 ACRYLIC RESIN - SPARKLE?

ORTHO-JET ACRYLIC RESIN - SPARKLE is a medical device that received FDA 510(k) clearance on 1994-05-27. The listed applicant is Lang Dental Mfg. Co., Inc.. The 510(k) number is K941925.

When did ORTHO-JET ACRYLIC RESIN - SPARKLE receive FDA 510(k) clearance?

ORTHO-JET ACRYLIC RESIN - SPARKLE received FDA 510(k) clearance on 1994-05-27, under 510(k) number K941925.

Who is the listed applicant for ORTHO-JET ACRYLIC RESIN - SPARKLE?

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 ACRYLIC RESIN - SPARKLE?

The FDA product code for ORTHO-JET ACRYLIC RESIN - SPARKLE is EBI.

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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 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 RESIN

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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.

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