Smileloc® BY RODO

Basic Information

• Brand Name: Smileloc® BY RODO
• Primary DI: 00816131021827
• Version / Model: 32.001
• Catalog Number: 32.001
• Company Name: RODO MEDICAL, INC.
• Labeler DUNS: 004584361
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-18
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 8e735e9e-5dfc-46c6-b91f-2aa1bf20ed9f

Device Description

Disposable Tip

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NHA	ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS	Dental	872.3630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62500	Dental prosthesis thermal detacher tip	A removable endpiece intended to be attached to a dental prosthesis thermal detacher handle to apply heat to a dental prosthesis (e.g., crown, denture, bridge) in order to unlock it from an implant abutment. It is used for abutments designed to be disengaged by heat (i.e., excludes those applied with cement or screws). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816131021827	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K160786	000