FDA.reportPublic FDA data

NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS

Primary DI
07630031708564
Brand
NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS
Company
Institut Straumann AG
Model
Final Abutments
Catalog number
022.2834
Device description
NC Straumann® Anatomic IPS e.max® Abutment, straight, GH 3.5mm, MO 1, ZrO2
Published
2015-09-24
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
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110580000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110580000NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTSStraumann USA2011-08-12NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630031708564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630031708564076300317085647630031708564

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)448-8168info.usa@straumann.com

Regulatory Flags#

DUNS number
483599259
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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07630031778222NAsurgically Invasive Instruments066.50772026-06-03
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07630031778307NAsurgically Invasive Instruments066.50852026-06-03
07630031778338NAsurgically Invasive Instruments066.50882026-06-03

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