FDA.reportPublic FDA data

Touareg™-S Dental Implant 3.5D 18L

Primary DI
07290105151001
Brand
Touareg™-S Dental Implant 3.5D 18L
Company
ADIN DENTAL IMPLANT SYSTEMS LTD
Model
ISPS1835
Published
2020-12-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290105151001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290105151001072901051510017290105151001

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533289435
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290116777658OnePiece Wrench RatchetRA10002025-12-18
07290116777665OnePiece Ratchet Hexagon AdapterRA10012025-12-18
07290116777672OnePiece Prosthetic Torque Ratchet 35 NcmRA10352025-12-18
07290116777689OnePiece Surgical Torque Ratchet 80 NcmRA10802025-12-18
07290116777696OnePiece Surgical Torque Ratchet 200 NcmRA12002025-12-18
07290116777702OnePiece UniV Wrench RatchetRA20002025-12-18
07290116777719OnePiece Standard Prosthetic Torque Ratchet 35NcmRA20352025-12-18
07290116777726OnePiece Pro Surgical Torque Ratchet 80NcmRA20802025-12-18
07290116777733OnePiece Elite Surgical Torque Ratchet 200Ncm RA22002025-12-18
07290116777740Star Hand Driver - Extra Long RP00092025-12-18
07290116777757Star Handpiece Driver - Extra Long RP00292025-12-18
07290116777764Star Torque Driver - Extra Long RP00362025-12-18
07290116777771Angulated Star Screw Hand Driver - Extra Long RP64082025-12-18
07290116777788Angulated Star Screw Torque Driver - Extra Long RP64092025-12-18
072901167778181.27 Hex Torque Driver - Extra Long RS60842025-12-18
072901167778251.27 Hex Driver for Handpiece - Extra Long RS90372025-12-18
07290116778327TorqLine™ 1.27 Hex Driver - ShortPT10102025-12-18
07290116778334TorqLine™ 1.27 Hex Driver - MediumPT10182025-12-18
07290116778341TorqLine™ 1.27 Hex Driver - LongPT10262025-12-18
07290116778358TorqLine™ Star Driver - ShortPT30102025-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840481135989LOCATORZest Anchors, LLCDZE2026-05-22
00840481135996LOCATORZest Anchors, LLCDZE2026-05-22
00840481136009LOCATORZest Anchors, LLCDZE2026-05-22
08806395269907ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269914ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269921ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269938ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269945ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269952ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269969ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269976ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269983ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269990ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395270002ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395270019ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395270026ABBA-ST Strong Co., Ltd.DZE2026-05-22
088000968507858plant Implant System8dent Inc.DZE2026-03-24
088000968507928plant Implant System8dent Inc.DZE2026-03-24
088000968507788plant Implant System8dent Inc.DZE2026-03-23
08800362100002DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100019DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100026DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100033DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100040DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100057DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100064DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100071DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100088DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100095DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100101DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20