ERA® Micro DO SP Basic Kit w/ Tools SS

Basic Information

• Brand Name: ERA® Micro DO SP Basic Kit w/ Tools SS
• Primary DI: 00841549101830
• Version / Model: 811413
• Company Name: STERNGOLD DENTAL LLC
• Labeler DUNS: 124763728
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-07
• Public Version: 2
• Public Version Date: 2023-07-26
• Public Version Status: Update
• Public Device Record Key: 4224b33a-3bef-41b8-98aa-19bbc435549f
• Distribution End Date: 2023-07-25

Device Description

Resilient precision attachment. Kit Contains: Three Micro small post females, (2-0°& 1-11°) Males, 3 sets of 5,(two each of white and black and one orange), 2 metal jackets, 2 Alignment handles,2 blockout spacers, 1 of each pilot drill, countersink bur, core cutter bur and seating tool

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Expiration Date: No
• 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
EGG	Attachment, Precision, All	Dental	872.3165	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38603	Resilient dental precision attachment	A dental fixation device designed to give a tooth-borne/tissue-borne prosthesis sufficient mechanical play to withstand the variations in the seating of the prosthesis due to deformation of the underlying tissues, without placing excessive stress on the abutments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841549101830	GS1

Customer Contacts

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