RESINCAP POWDER 2350RED

GUDID D6502350RED0

PATTERN, COPING AND INLAY ACRYLIC RESIN POWDER

LANG DENTAL MANUFACTURING CO., INC.

Temporary dental crown/bridge resin

• Primary Device ID: D6502350RED0
• NIH Device Record Key: d12eba4f-af59-4b31-976e-06c6e5dcb8fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESINCAP POWDER
• Version Model Number: 2.3 KG
• Catalog Number: 2350RED
• 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	D6502350RED0 [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

On-Brand Devices [RESINCAP POWDER]

• D6502390RED0: PATTERN, COPING AND INLAY ACRYLIC RESIN POWDER
• D6502380RED0: PATTERN, COPING AND INLAY ACRYLIC RESIN POWDER
• D6502370RED0: PATTERN, COPING AND INLAY ACRYLIC RESIN POWDER
• D6502350RED0: PATTERN, COPING AND INLAY ACRYLIC RESIN POWDER
• D6502310RED0: PATTERN, COPING AND INLAY ACRYLIC RESIN POWDER