TEMPO 1034P1

GUDID D6501034P10

CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN POWDER AND LIQUID

LANG DENTAL MANUFACTURING CO., INC.

Denture reliner, soft, professional

• Primary Device ID: D6501034P10
• NIH Device Record Key: fdf34dfe-6562-4366-9b44-45b84687f433
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEMPO
• Version Model Number: POUND PACKAGE P1
• Catalog Number: 1034P1
• 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	D6501034P10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081514

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-25
• Device Publish Date: 2022-04-15

On-Brand Devices [TEMPO]

• D6501050P10: CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN POWDER
• D6501034P10: CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN POWDER AND LIQUID
• D6501030P10: CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN POWDER
• D6501023P10: CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN POWDER AND LIQUID
• D6501020P10: CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN POWDER