BioTemps 70-1181-MIL0091

GUDID D745701181MIL00910

BioTemps NOW Milling Blocks; Bridge Block; A2 (5-pack)

James R. Glidewell, Dental Ceramics, Inc.

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• Primary Device ID: D745701181MIL00910
• NIH Device Record Key: 11b8109f-b606-4493-ad2c-f533e00c0193
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioTemps
• Version Model Number: 70-1181-MIL0091
• Catalog Number: 70-1181-MIL0091
• Company DUNS: 021228671
• Company Name: James R. Glidewell, Dental Ceramics, Inc.
• Device Count: 5
• 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

Customer Support Contacts

• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
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Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D745701181MIL00910 [Unit of Use]
HIBCC	D745701181MIL00911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201683

FDA Product Code

• MQC: Mouthguard, prescription

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: 2021-06-03
• Device Publish Date: 2021-05-26

On-Brand Devices [BioTemps]

• D745701181MIL00960: BioTemps NOW Milling Blocks; Bridge Block; BL (5-pack)
• D745701181MIL00950: BioTemps NOW Milling Blocks; Bridge Block; C2 (5-pack)
• D745701181MIL00940: BioTemps NOW Milling Blocks; Bridge Block; B1 (5-pack)
• D745701181MIL00930: BioTemps NOW Milling Blocks; Bridge Block; A3.5 (5-pack)
• D745701181MIL00920: BioTemps NOW Milling Blocks; Bridge Block; A3 (5-pack)
• D745701181MIL00910: BioTemps NOW Milling Blocks; Bridge Block; A2 (5-pack)
• D745701181MIL00900: BioTemps NOW Milling Blocks; Bridge Block; A1 (5-pack)
• D745701181MIL00341: Biotemps NOW Milling Blocks; GD-Mandrel; BL (5 units)
• D745701181MIL00331: Biotemps NOW Milling Blocks; GD-Mandrel; C2 (5 units)
• D745701181MIL00321: Biotemps NOW Milling Blocks; GD-Mandrel; B1 (5 units)
• D745701181MIL00311: Biotemps NOW Milling Blocks; GD-Mandrel; A3.5 (5 units)
• D745701181MIL00301: Biotemps NOW Milling Blocks; GD-Mandrel; A3 (5 units)
• D745701181MIL00291: Biotemps NOW Milling Blocks; GD-Mandrel; A2 (5 units)
• D745701181MIL00281: Biotemps NOW Milling Blocks; GD-Mandrel; A1 (5 units)