FDA.reportPublic FDA data

ASTRA TECH Implant System®

Primary DI
07392532003103
Brand
ASTRA TECH Implant System®
Company
Dentsply Implants Manufacturing GmbH
Model
22851
Catalog number
22851
Device description
TempDesign™ 3.5/4.0 - Ø4.1, 1 mm
Published
2015-10-16
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
07392532003103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07392532003103073925320031037392532003103

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07392532218965ANKYLOS®31033623310336232022-07-14
07392532220456ANKYLOS®31037500310375002022-07-14
07392532230011XiVE®45-601045-60102022-07-14
07392532230028XiVE®45-602045-60202022-07-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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D990EK2A0Essentials Kit, 2 ArchSMART DENTURE CONVERSIONS, LLCNHA2026-07-13
07290114710411Healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712156Abutments-AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712613Titanium-basesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
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05712821017147Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017154Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017161Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
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05712821017185Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017192Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017208Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017215Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017222Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017239Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017246Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017253Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017260Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017277Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017284Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017291Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017307Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017314Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017321Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017338Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017345Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017352Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
D99025HMINIOA0Omnibut, Hiossen Mini, 2.5GHSMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025HMINIOA140Omnibut, Hiossen Mini, 2.5GH, M1.4SMART DENTURE CONVERSIONS, LLCNHA2026-06-26