FDA.report

NA

Primary DI
07630031724502
Brand
NA
Company
Institut Straumann AG
Model
Bars
Catalog number
048.413
Device description
Dolder bar matrix, mini, incl. spacer, H 2.75mm, L 25mm, Elitor®/brass
Published
2022-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EHOBAR, PREFORMED

Product Code Classifications

CodeDeviceSpecialtyClass
EHOBar, PreformedDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07630031724502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07630031724502076300317245027630031724502

GMDN Terms

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

TypeValueUnit
Height2.75Millimeter
Length25Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)448-8168info.usa@straumann.com

Regulatory Flags

DUNS number
483599259
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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