FDA.reportPublic FDA data

ITI DISTANCE SYSTEM

Primary DI
07630031724588
Brand
ITI DISTANCE SYSTEM
Company
Institut Straumann AG
Model
Edentulous Abutments
Catalog number
048.432
Device description
Bone Graft Retentive anchor, height 3.9 mm, titanium
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
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931993000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931993000ITI DISTANCE SYSTEMThe Straumann Co.1994-04-26DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630031724588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630031724588076300317245887630031724588

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
Moist Heat or Steam 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
Primary DIBrandModelCatalogPublished
07630031764263Straumann® BLC Implants - Indication WideningSLA Roxolid BL035.8218S2023-11-04
07630031764331Straumann® BLC Implants - Indication WideningSLActive Roxolid BL035.9218S2023-11-04
07630031778086NAsurgically Invasive Instruments066.50632026-06-03
07630031778093NAsurgically Invasive Instruments066.50642026-06-03
07630031778109NAsurgically Invasive Instruments066.50652026-06-03
07630031778116NAsurgically Invasive Instruments066.50662026-06-03
07630031778123NAsurgically Invasive Instruments066.50672026-06-03
07630031778130NAsurgically Invasive Instruments066.50682026-06-03
07630031778147NAsurgically Invasive Instruments066.50692026-06-03
07630031778154NAsurgically Invasive Instruments066.50702026-06-03
07630031778161NAsurgically Invasive Instruments066.50712026-06-03
07630031778192NAsurgically Invasive Instruments066.50742026-06-03
07630031778208NAsurgically Invasive Instruments066.50752026-06-03
07630031778215NAsurgically Invasive Instruments066.50762026-06-03
07630031778222NAsurgically Invasive Instruments066.50772026-06-03
07630031778239NAsurgically Invasive Instruments066.50782026-06-03
07630031778260NAsurgically Invasive Instruments066.50812026-06-03
07630031778277NAsurgically Invasive Instruments066.50822026-06-03
07630031778284NAsurgically Invasive Instruments066.50832026-06-03
07630031778291NAsurgically Invasive Instruments066.50842026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070230008ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-07-29
08800070201619ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-07-27
08800070218600ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-07-27
08800070218891ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-07-27
08800070228333ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-07-27
00810126046871ET III Fixture SA Regular No MountHIOSSEN, INC.DZE2026-07-14
07290112780010Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780522Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780645Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780652Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781215Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781222Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781246Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781260Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781284Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781710Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781727Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290114710565AbutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
08800070203415ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203422ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203439ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203446ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228975ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228982ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228999ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229002ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229019ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26