SYNOCTA PROSTHETICS

Basic Information

• Brand Name: SYNOCTA PROSTHETICS
• Primary DI: 07630031725608
• Version / Model: 1
• Catalog Number: 048.661
• Company Name: Institut Straumann AG
• Labeler DUNS: 483599259
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 8039c8a9-b6b0-4da0-accd-b3a1e2b31573

Device Description

RN synOcta® Plastic Coping, Crown, H 13.3mm, POM

Device Characteristics

• Single Use: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZE	IMPLANT, ENDOSSEOUS, ROOT-FORM	Dental	872.3640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16189	Dental casting wax	A waxy dental material used to make patterns in the production of fixed dental prosthetic restorations by the "lost-wax" casting technique. 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	07630031725608	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K990342	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			H 13.3mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight