Biotemps 70-1181-MIL0032

GUDID D745701181MIL00321

Biotemps NOW Milling Blocks; GD-Mandrel; B1 (5 units)

James R. Glidewell, Dental Ceramics, Inc.

Temporary dental crown/bridge

• Primary Device ID: D745701181MIL00321
• NIH Device Record Key: dcd89f3b-746a-40a7-bdbc-e49e09f9de93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotemps
• Version Model Number: 70-1181-MIL0032
• Catalog Number: 70-1181-MIL0032
• 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
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 33 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D745701181MIL00320 [Unit of Use]
HIBCC	D745701181MIL00321 [Primary]

FDA Product Code

• EBG: CROWN AND BRIDGE, TEMPORARY, RESIN

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-10-29
• Device Publish Date: 2018-08-31

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)