Device
Sample ClearTemp LC Temporary Veneer Cement
Manufacturer
ULTRADENT PRODUCTS, INC.
Model: S3518 Catalog: S3518 DI: 00883205045782 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-04-28 Current Version: 2026-05-06
Description
Sample ClearTemp LC Temporary Veneer Cement
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 1217d35c-a4f9-4b86-badc-69252a569095
Distribution Status: In Commercial Distribution
DUNS Number: 013369913
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: Yes
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00883205045782
Type: Primary
Issuing Agency: GS1
GMDN
Code: 35870
Name: Dental composite resin
Definition:
A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.
FDA Product Codes
EMA
CEMENT, DENTAL
Premarket Submissions
Submission Number: K111017
Supplement Number: 000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit: Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value: 2
Storage Handling - Storage Handling High - @attributes - Unit: Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value: 8
Storage Handling - Storage Handling Type: Storage Environment Temperature