BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Set PP

DI: DO3688100041 · Model: SET PP MIXING TIPS (WIDE) · SDI LIMITED

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

10

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Basic Information

Brand Name: Set PP
Primary DI: DO3688100041
Version / Model: SET PP MIXING TIPS (WIDE)
Catalog Number: 8810004
Company Name: SDI LIMITED
Labeler DUNS: 753221852
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 10
Record Status: Published
Publish Date: 2016-10-10
Public Version: 4
Public Version Date: 2025-01-13
Public Version Status: Update
Public Device Record Key: 616de356-01a2-44ec-aea2-233ddf8cd914
Distribution End Date: 2025-01-12

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
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: Yes
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
EMA	CEMENT, DENTAL	Dental	872.3275	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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
Primary	DO3688100041	HIBCC
Unit of Use	DO3688100040	HIBCC

Customer Contacts

Phone: +18002285166
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K073043	000

Storage Conditions

Type: Handling Environment Atmospheric Pressure
Temperature Range: 2 – 8 Degrees Celsius