SmarTemp® S346-B1

GUDID 00810000525508

SmarTemp® X1 Shade B1 (50ml 10:1 Cartridge)

PARKELL, INC.

Dental crown/bridge resin, temporary

• Primary Device ID: 00810000525508
• NIH Device Record Key: 0f7fdca9-f906-47a6-8053-b6ad2699b15a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmarTemp®
• Version Model Number: S346-B1
• Catalog Number: S346-B1
• Company DUNS: 009900424
• Company Name: PARKELL, 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: false
• 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: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do Not store in Refrigerator. Store tightly sealed, away from direct light and eugenol-containing products. Do not freeze. Use at room temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000525508 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-07
• Device Publish Date: 2019-09-27

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