SmarTemp® S340

GUDID 00810000525300

Light A2 SmarTemp® in 50ml. Cartridge

PARKELL, INC.

Dental crown/bridge resin, temporary

• Primary Device ID: 00810000525300
• NIH Device Record Key: c5a5ac71-586e-46eb-b3af-5a60f084c1b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmarTemp®
• Version Model Number: S340
• Catalog Number: S340
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
• Storage Environment Temperature: Between 7 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
• Storage Environment Temperature: Between 7 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
• Storage Environment Temperature: Between 7 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
• Storage Environment Temperature: Between 7 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
• Storage Environment Temperature: Between 7 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
• Storage Environment Temperature: Between 7 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
• Storage Environment Temperature: Between 7 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
• Storage Environment Temperature: Between 7 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
• Storage Environment Temperature: Between 7 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
• Storage Environment Temperature: Between 7 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
• Storage Environment Temperature: Between 7 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
• Storage Environment Temperature: Between 7 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
• Storage Environment Temperature: Between 7 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
• Storage Environment Temperature: Between 7 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
• Storage Environment Temperature: Between 7 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.
• Storage Environment Temperature: Between 7 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration is preferred to prolong shelf-life. However, for optimal setting characteristics, warm to room temperature before use. Avoid sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000525300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991270

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: 2
• Public Version Date: 2019-09-20
• Device Publish Date: 2018-10-26

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• 00810000525287: Ultralight A1 SmarTemp® Split 50ml. Cartridge
• M595S3410: Medium A3.5 SmarTemp® 50ml. Cartridge
• M595S3400: Light A2 SmarTemp® 50ml. Cartridge
• M595S3380: Dual Cure A2 (Light Shade) SmarTemp® 50ml. Cartridge
• M595S3370: Ultralight A1 SmarTemp® Split 50ml. Cartridge
• 10810000528124: SmarTemp® X1 10:1 50ml Mixing Tip Refill (30 pieces)
• 00810000528134: 10:1 50ml Split Cartridge Dispensing Gun for SmarTemp® X1
• 00810000525515: SmarTemp® X1 Shade Bleach (50ml 10:1 Cartridge)
• 00810000525508: SmarTemp® X1 Shade B1 (50ml 10:1 Cartridge)
• 00810000525492: SmarTemp® X1 Shade A3 (50ml 10:1 Cartridge)
• 00810000525485: SmarTemp® X1 Shade A2 (50ml 10:1 Cartridge)
• 00810000525478: SmarTemp® X1 Shade A1 (50ml 10:1 Cartridge)
• 10810000526953: Mixing Tip with Blue Base for 50ml SmarTemp® (Pkg. of 30 pcs.)