FDA.reportPublic FDA data

ERA® Micro Partial Metal Jacket

Primary DI
00841549100758
Brand
ERA® Micro Partial Metal Jacket
Company
STERNGOLD DENTAL LLC
Model
811021
Device description
Attachments are two-part connectors. One part is intraorally fixed as part of a fixed (i.e. not patient removable) dental restoration, and a replaceable, high density nylon male anchored into a patient removable dental prosthesis (denture base). When the removable prosthesis is seated in the mouth the attachment parts come together and secure it in place. In other applications the attachment connects two sections of a segmented fixed partial denture.
Published
2017-02-21
Public version status
Update
Distribution status
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
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGGAttachment, Precision, AllDental1
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020391000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020391000STERN MICRO ERA ATTACHMENT SYSTEMSterngold2002-03-08DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841549100758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841549100758008415491007588415491007580841549100758

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
401-871-3489maria.rao@sterngold.com

Regulatory Flags#

DUNS number
124763728
Device count
1
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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