DELTON®

Basic Information

• Brand Name: DELTON®
• Primary DI: D0033101011
• Version / Model: 310101
• Company Name: Dentsply Professional
• Labeler DUNS: 144140845
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 0277a859-b62b-4d52-97d4-187f4767d9c8

Device Description

DELTON® FS+ FLOWABLE Pit & Fissure Sealant with FLUORIDE Light Curing Opaque. Also contains: Delton® Syringes, EZ Etch Syringe, EZ Tips, and Syringe Sleeves.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBC	SEALANT, PIT AND FISSURE, AND CONDITIONER	Dental	872.3765	2
PEM	Dental barriers and sleeves	General, Plastic Surgery	878.4370	2
EFB	HANDPIECE, AIR-POWERED, DENTAL	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33878	Cable/lead/sensor/probe cover, non-sterile	A non-sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier to protect the contents from soiling and contamination so that the non-sterile contents may be used in the vicinity of, or enter into a hygienic area, e.g., a sterile surgical field. This is a single-use device.	No	Obsolete
35870	Dental composite resin	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D0033101012	HIBCC	Case	12	In Commercial Distribution
Primary	D0033101011	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Weight	1.9	Gram

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep out of direct sunlight. Keep away from rain.
• Type: Storage Environment Temperature
• Temperature Range: 5 – 24 Degrees Celsius