Glidewell™ 70-1071-PRS0004

GUDID D745701071PRS00040

Glidewell™ Prosthetic Kit

Prismatik Dentalcraft, Inc

Instrument tray, reusable

• Primary Device ID: D745701071PRS00040
• NIH Device Record Key: a6f10026-d09d-4ff2-a377-e38b95c850f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glidewell™
• Version Model Number: 70-1071-PRS0004
• Catalog Number: 70-1071-PRS0004
• Company DUNS: 022761689
• Company Name: Prismatik Dentalcraft, 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)402-1725
• Email: xx@xx.xx
• Phone: +1(888)402-1725
• Email: xx@xx.xx
• Phone: +1(888)402-1725
• Email: xx@xx.xx
• Phone: +1(888)402-1725
• Email: xx@xx.xx
• Phone: +1(888)402-1725
• Email: xx@xx.xx
• Phone: +1(888)402-1725
• Email: xx@xx.xx
• Phone: +1(888)402-1725
• Email: xx@xx.xx
• Phone: +1(888)402-1725
• Email: xx@xx.xx
• Phone: +1(888)402-1725
• Email: xx@xx.xx
• Phone: +1(888)402-1725
• Email: xx@xx.xx
• Phone: +1(888)402-1725
• Email: xx@xx.xx
• Phone: +1(888)402-1725
• Email: xx@xx.xx
• Phone: +1(888)402-1725
• Email: xx@xx.xx
• Phone: +1(888)402-1725
• Email: xx@xx.xx
• Phone: +1(888)402-1725
• Email: xx@xx.xx
• Phone: +1(888)402-1725
• Email: xx@xx.xx

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dry place at room temperature.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D745701071PRS00040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242564

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

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

[D745701071PRS00040]

Moist Heat or Steam Sterilization

[D745701071PRS00040]

Moist Heat or Steam Sterilization

[D745701071PRS00040]

Moist Heat or Steam Sterilization

[D745701071PRS00040]

Moist Heat or Steam Sterilization

[D745701071PRS00040]

Moist Heat or Steam Sterilization

[D745701071PRS00040]

Moist Heat or Steam Sterilization

[D745701071PRS00040]

Moist Heat or Steam Sterilization

[D745701071PRS00040]

Moist Heat or Steam Sterilization

[D745701071PRS00040]

Moist Heat or Steam Sterilization

[D745701071PRS00040]

Moist Heat or Steam Sterilization

[D745701071PRS00040]

Moist Heat or Steam Sterilization

[D745701071PRS00040]

Moist Heat or Steam Sterilization

[D745701071PRS00040]

Moist Heat or Steam Sterilization

[D745701071PRS00040]

Moist Heat or Steam Sterilization

[D745701071PRS00040]

Moist Heat or Steam Sterilization

[D745701071PRS00040]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-29
• Device Publish Date: 2025-04-21

On-Brand Devices [Glidewell™]

• D745701204WPS00011: Glidewell™ Curing Light Kit
• D745701071PRS00050: Autoclavable Cassette for Glidewell™ Prosthetic Kit
• D745701071PRS00040: Glidewell™ Prosthetic Kit