PRESIDENT The Original 60019938

GUDID 07640370883907

PRESIDENT The Original light body 2 x 50 ml

Coltène/Whaledent AG

Silicone dental impression material

• Primary Device ID: 07640370883907
• NIH Device Record Key: f78b712f-d91f-4a46-8bf7-4bdd7eccc3aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRESIDENT The Original
• Version Model Number: 60019938
• Catalog Number: 60019938
• Company DUNS: 480017482
• Company Name: Coltène/Whaledent AG
• Device Count: 2
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640181479597 [Primary]
GS1	07640370883907 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220097

FDA Product Code

• ELW: Material, Impression

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: 2022-02-21
• Device Publish Date: 2022-02-11

On-Brand Devices [PRESIDENT The Original]

• 07640370883747: PRESIDENT The Original fast putty soft 2 x 300 ml
• 07640181479719: PRESIDENT The Original regular body 2 x 53 ml
• 07640181479702: PRESIDENT The Original light body 2 x 53 ml
• 07640370884201: PRESIDENT The Original heavy body System 360 Refill, 2 x 380 ml
• 07640181479689: PRESIDENT The Original heavy body System 360 Starter Kit, 1 x 380 ml
• 07640370884393: PRESIDENT The Original MonoBody System 360 Refill, 2 x 380 ml
• 07640181479665: PRESIDENT The Original MonoBody System 360 Starter Kit, 1 x 380 ml
• 07640181479658: PRESIDENT The Original putty super soft 2 x 300 ml
• 07640181479641: PRESIDENT The Original putty soft 2 x 300 ml
• 07640181479634: PRESIDENT The Original putty 2 x 300 ml
• 07640370884386: PRESIDENT The Original heavy body 2 x 75ml
• 07640370884423: PRESIDENT The Original regular body 2 x 50ml
• 07640370883907: PRESIDENT The Original light body 2 x 50 ml
• 07640181479580: PRESIDENT The Original xtra light body 2 x 50ml