RP Low Margin Abutment 3.0mm Cuff

Primary DI
00841549111167
Brand
RP Low Margin Abutment 3.0mm Cuff
Company
STERNGOLD DENTAL LLC
Model
904354
Device description
The RP Low Margin Abutments allow for more aesthetic restorations than are possible with conventional standard abutments. Due to the abutment's conical shape, restorative components are unique to the system; yet the same restorative procedures and instrumentation are used. Available in 1.0mm, 2.0mm, 3.0mm, 4.0mm, 5.0mm cuff sizes. They accommodate up to 25% of total divergence between implants. Small diameter allows use at mandibular anterior sites. Intended 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 abutment screws directly into endosseous implants or they screw into Abutment Bases which are screwed into endosseous implants.
Published
2017-06-01
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
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K946198000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K946198000IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTECTORSterngold1995-06-14DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841549111167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841549111167008415491111678415491111670841549111167

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

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

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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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