TEMPO POWDER 1070P1

GUDID D6501070P10

CUSHION TREATMENT DENTURE REPAIR RELINE ACRYLIC RESIN POWDER

LANG DENTAL MANUFACTURING CO., INC.

Denture reliner, soft, professional

• Primary Device ID: D6501070P10
• NIH Device Record Key: 6c48d0a7-f3bf-44ef-be1f-9c3ef07c587c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEMPO POWDER
• Version Model Number: 11.3 KG P1
• Catalog Number: 1070P1
• 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	D6501070P10 [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: 2023-07-05
• Device Publish Date: 2023-06-27

Devices Manufactured by LANG DENTAL MANUFACTURING CO., INC.

• D6500270C0 - ORTHO-JET CRYSTAL POWDER: 2023-07-05 FAST CURING EXTRA CLEAR ORTHODONTIC ACRYLIC RESIN POWDER
• 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: 2023-07-05CUSHION TREATMENT DENTURE REPAIR 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