PRESIDENT The Original 60019937

GUDID 07640181479580

PRESIDENT The Original xtra light body 2 x 50ml

Coltène/Whaledent AG

Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material

• Primary Device ID: 07640181479580
• NIH Device Record Key: ca8ca6ff-a5f6-412b-83bb-f53476f800c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRESIDENT The Original
• Version Model Number: 60019937
• Catalog Number: 60019937
• 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	07640181479580 [Primary]
GS1	07640370884409 [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