ERA® DO LP Master Kit w/ Tools SS

Primary DI
00841549101755
Brand
ERA® DO LP Master Kit w/ Tools SS
Company
STERNGOLD DENTAL LLC
Model
811402
Device description
This part contains:Five Large post females, (2- 0° , 1 each 5°, 11°, and 17°), Males, 5 sets of 5, (two each of white and black and one orange), 2 metal jackets, 2 Processing jigs, 2 alignment handles, 2 blockout spacers, 1 of each Gutta percha drill, pilot drill, countersink bur, core cutter bur and seating tool. These attachments are placed in the retained tooth root, which has been prepared to receive the fixed attachment component. The other component of the attachment becomes part of a patient removable overdenture, which is a denture partially supported by one or more retained roots. ERA Direct Placement Overdenture is available in standard and micro sizes. An optional metal jacket is also available to hold the attachment male in the denture base and is sold pre-loaded with a black fabrication male. Intended to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function.
Published
2020-07-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGGAttachment, Precision, All

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGGAttachment, Precision, AllDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841549101755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841549101755008415491017558415491017550841549101755

GMDN Terms#

Term, Definition table
TermDefinition
Resilient dental precision attachmentA 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5082265660laura.greige@sterngold.com

Regulatory Flags#

DUNS number
124763728
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841549118517SternTek Duplicating Material2220122023-10-04
00841549101823ERA® DO LP Basic Kit w/ Tools SS 8114122020-07-07
00841549115042Sterngold Implant System Cortical Bone Drill 3.2mm 9055222020-07-07
00841549103841ERA® Implant Abutment Micro 0°, 4mm Cuff (AX)8124352017-03-21
00841549103889ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (BD)8125322017-03-21
00841549103896ERA® Implant Abutment Micro Ang. Base, 3mm Cuff (BD)8125332017-03-21
00841549103902ERA® Implant Abutment Micro Ang. Base, 4mm Cuff (BD)8125342017-03-21
00841549103919ERA® Implant Abutment Micro Ang. Base, 5mm Cuff (BD)8125352017-03-21
00841549103926ERA® Implant Abutment Micro Ang. Base, 6mm Cuff (BD)8125362017-03-21
00841549103933ERA® Implant Abutment Micro 0°, 0.5mm Cuff (BD)8125372017-03-21
00841549103940ERA® Implant Abutment Micro 0°, 2mm Cuff (BD)8125382017-03-21
00841549103957ERA® Implant Abutment Micro 0°, 3mm Cuff (BD)8125392017-03-21
00841549103964ERA® Implant Abutment Micro 0°, 4mm Cuff (BD)8125402017-03-21
00841549103988ERA® Implant Abutment Micro 0°, 6mm Cuff (BD)8125422017-03-22
00841549103995ERA® Implant Abutment Micro Ang. Base, 1mm Cuff (BE)8125432017-03-22
00841549104008ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (BE)8125442017-03-22
00841549104015ERA® Implant Abutment Micro Ang. Base, 3mm Cuff (BE)8125452017-03-22
00841549104022ERA® Implant Abutment Micro Ang. Base, 4mm Cuff (BE)8125462017-03-22
00841549104039ERA® Implant Abutment Micro Ang. Base, 5mm Cuff (BE)8125472017-03-22
00841549104046ERA® Implant Abutment Micro Ang. Base, 6mm Cuff (BE)8125482017-03-22

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