Peak SE 5135

GUDID 00883205104311

Peak SE Primer Refill

ULTRADENT PRODUCTS, INC.

Dentine adhesive

• Primary Device ID: 00883205104311
• NIH Device Record Key: ec7bc548-a9bc-4013-bb8d-83dcf79ea69d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Peak SE
• Version Model Number: 5135
• Catalog Number: 5135
• Company DUNS: 013369913
• Company Name: ULTRADENT PRODUCTS, 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: +1(801)572-4200
• Email: customerservice@ultradent.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205104311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063558

FDA Product Code

• KLE: AGENT, TOOTH BONDING, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

Devices Manufactured by ULTRADENT PRODUCTS, INC.

• 00883205031778 - Ultrapak: 2024-04-03 Sample Cord Ultradent
• 00883205034168 - VALO: 2024-03-04 VALO X ProxiCure Ball Lens 2pk
• 00883205034175 - VALO: 2024-03-04 VALO X PointCure Lens 2pk
• 00883205034182 - VALO: 2024-03-04 VALO X TransLume Lens 2pk
• 00883205034199 - VALO: 2024-03-04 VALO X Interproximal Lens 2pk
• 00883205034205 - VALO: 2024-03-04 VALO X Diffuser Lens 1pk
• 00883205027948 - PermaShade Try-In Paste: 2024-01-19 PermaShade Try-In Paste Kit
• 00883205027955 - PermaShade Try-In Paste: 2024-01-19 PermaShade Try-In Paste Translucent Refill