Precision® SPD1536

GUDID D813SPD15360

PRECISION FATPAK INTRO MED

DEN-MAT HOLDINGS, LLC

Silicone dental impression material

• Primary Device ID: D813SPD15360
• NIH Device Record Key: c56fbb66-d4d8-43d6-a0f8-f95e5f7af6ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision®
• Version Model Number: SPD1536
• Catalog Number: SPD1536
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• 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: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D813SPD15360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040053

FDA Product Code

• ELW: Material, Impression

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: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Precision®]

• D813SPD15470: PRECISION JUMBO CART RFL HVY
• D813SPD15460: PRECISION JUMBO CART RFL MED
• D813SPD15360: PRECISION FATPAK INTRO MED
• D813SPD15350: PRECISION FATPAK INTRO HVY
• D813SPD15340: PRECISION FATPAK REFILL MED
• D813SPD15330: PRECISION FATPAK REFILL HVY
• D813SPD15170: PREC JAR PTY WILD BRY
• D813SPD15141: PREC PTY PK WILD BRY
• D813SPD15110: PREC HVY WILD BRY
• D813SPD15100: PREC MED WILD BRY
• D813SPD15090: PREC LITE WILD BRY
• D813SPD15080: PREC XLITE BODY WILD BRY