FDA.reportPublic FDA data

ANKYLOS®

Primary DI
07392532222450
Brand
ANKYLOS®
Company
Dentsply Implants Manufacturing GmbH
Model
31056217
Catalog number
31056217
Device description
Retention Coping long for Balance Base Abutment narrow
Published
2020-11-18
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EFRI310562172PreviousHIBCC0
07392532222450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07392532222450073925322224507392532222450

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage, in the original packaging, at room temperature in a dry place away from sunlight.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)531-3481implants-na-cs@dentsplysirona.com

Regulatory Flags#

DUNS number
344038836
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07392532220166ANKYLOS®31037206310372062022-07-14
07392532218590ANKYLOS®31033370310333702025-10-17
07392532171673Astra Tech Implant System®25855258552022-11-11
07392532233661FRIOS®90-503790-50372022-07-15
07392532233678FRIOS®90-503890-50382022-07-15
07392532233920FRIADENT®91-451091-45102022-07-15
07392532066993Astra Tech Implant System®24573245732022-07-14
07392532072963Astra Tech Implant System®24801248012022-07-14
07392532151644Astra Tech Implant System®25721257212022-07-14
07392532151651Astra Tech Implant System®25722257222022-07-14
07392532151668Astra Tech Implant System®25723257232022-07-14
07392532151675Astra Tech Implant System®25769257692022-07-14
07392532169366Astra Tech Implant System®26098260982022-07-14
07392532169373Astra Tech Implant System®26099260992022-07-14
07392532218200ANKYLOS®31033030310330302022-07-14
07392532218224ANKYLOS®31033040310330402022-07-14
07392532218309ANKYLOS®31033095310330952022-07-14
07392532218606ANKYLOS®31033400310334002022-07-14
07392532219184ANKYLOS®31034350310343502022-07-14
07392532219191ANKYLOS®31034352310343522022-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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