Disposable Impression Bite Tray [BT-1000]

GUDID 08800017902050

Disposable Impression Bite Trays with stainless-steel edge frames used to make an impression of a patient's teeth or alveolar process (bony tooth sockets). Rigid construction with stainless-steel edge frames provides less distortion and firmly holds the impression. DIBT is specifically made thinner and longer for higher accuracy of impressions.

DXM CO., LTD

Dental impression tray, single-use

• Primary Device ID: 08800017902050
• NIH Device Record Key: 6fe26e13-235e-4630-ad74-5e64e8ccbc38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Impression Bite Tray
• Version Model Number: Side/Posterior
• Catalog Number: [BT-1000]
• Company DUNS: 688797315
• Company Name: DXM CO., LTD
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800017902043 [Primary]
GS1	08800017902050 [Package]; Contains: 08800017902043; Package: Box [35 Units]; In Commercial Distribution

FDA Product Code

• EBH: Material, Impression Tray, Resin

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: 2024-06-19
• Device Publish Date: 2024-06-11

On-Brand Devices [Disposable Impression Bite Tray]

• 08800017902098: Disposable Impression Bite Trays with stainless-steel edge frames used to make an impression of
• 08800017902067: Disposable Impression Bite Trays with stainless-steel edge frames used to make an impression of
• 08800017902050: Disposable Impression Bite Trays with stainless-steel edge frames used to make an impression of