RESINCAP 2312RED

GUDID D6502312RED0

PATTERN, COPING AND INLAY ACRYLIC RESIN POWDER AND LIQUID

LANG DENTAL MANUFACTURING CO., INC.

Temporary dental crown/bridge resin

• Primary Device ID: D6502312RED0
• NIH Device Record Key: 4337bb41-b67a-4dee-994b-16d0a4542e10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESINCAP
• Version Model Number: PROFESSIONAL PACKAGE
• Catalog Number: 2312RED
• Company DUNS: 005185798
• Company Name: LANG DENTAL MANUFACTURING CO., INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D6502312RED0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081705

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-29
• Device Publish Date: 2016-09-01

Devices Manufactured by LANG DENTAL MANUFACTURING CO., INC.

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• D6500934F10 - FLEXACRYL HARD: 2023-07-05 DENTURE RELINE ACRYLIC POWDER AND LIQUID
• D6500950CLR0 - FLEXACRYL: 2023-07-05 DENTURE RELINE ACRYLIC RESIN POWDER
• D6501070P10 - TEMPO POWDER: 2023-07-05 CUSHION TREATMENT DENTURE REPAIR RELINE ACRYLIC RESIN POWDER
• D6501330LS0 - ORTHO-JET POWDER: 2023-07-05 FAST CURING ORTHODONTIC ACRYLIC RESIN POWDER
• D6501356PT0 - ORTHO-JET: 2023-07-05 FAST CURING ORTHODONTIC ACRYLIC RESIN POWDER AND LIQUID
• D6501480LI0 - JET TOOTH SHADE POWDER: 2023-07-05 FAST CURING PROVISIONAL CROWN & BRIDGE ACRYLIC RESIN
• D6504720F20 - JET SET-4 DENTURE REPAIR: 2022-10-28 VERY FAST CURING DENTURE REPAIR ACRYLIC RESIN POWDER