FDA.reportPublic FDA data

Stern Snap One Piece Abutment 4mm Cuff (BK)

Primary DI
00841549119217
Brand
Stern Snap One Piece Abutment 4mm Cuff (BK)
Company
STERNGOLD DENTAL LLC
Model
904733
Device description
The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into Abutments which are screwed into endosseous implants.
Published
2024-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142407000Straight Stud AttachmentSterngold Dental, LLC2014-12-24NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841549119217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841549119217008415491192178415491192170841549119217

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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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