FDA.report

INTERNA IMPLANT, NARROW PLATFORM, CORE-X® CA D:4 L:7.5

Primary DI
08435389825418
Brand
INTERNA IMPLANT, NARROW PLATFORM, CORE-X® CA D:4 L:7.5
Company
BIOTECHNOLOGY INSTITUTE SL
Model
IIPEXCA4075
Catalog number
IIPEXCA4075
Published
2024-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08435389825418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08435389825418084353898254188435389825418

GMDN Terms

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

Regulatory Flags

DUNS number
461665312
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

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08435389829027SHORT DRILL; Ø2,2 MMF22CS2026-01-30
08435389829034SHORT DRILL; Ø2,3 MMF23CS2026-01-30
08435389829041SHORT DRILL; Ø2,4 MMF24CS2026-01-30
08435389829058SHORT DRILL; Ø2,0 MMF20CS2026-01-30
08435389829096FLATTENING FRONT CUTTING SHORT DRILL; Ø5.5 FCFA55C2026-01-30
08435389830061EXTRA SHORT INITIAL DRILLFIXS2026-01-30
08435389830078EXTRA SHORT DRILL; Ø1,8 MMF18XS2026-01-30
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08435389830092EXTRA SHORT DRILL; Ø2,5 MMF25XS2026-01-30
08435389830108EXTRA SHORT DRILL; Ø2,8 MMF28XS2026-01-30
08435389830115EXTRA SHORT DRILL; Ø3 MMF30XS2026-01-30
08435389830269HEATING OVEN H-PLUSBTI H-PLUS2026-01-30
08435389830276DRILL HOLDER FOR EXTRA SHORT DRILLSFFXS2026-01-30
08435389830320SHORT DRILL; Ø1.5 MMF15CS2026-01-30
08435389829706EXPANDED SQUARE INTERFACE; MULTI-IM ABUTMENT; WIDE PLATFORMISMIPAX2026-01-29
08435389829713EXPANDED SQUARE INTERFACE; UNIT ABUTMENT; WIDE PLATFORMISMIUPAX2026-01-29
08435389829843MULTI-IM ABUTMENT; INTERNA 3.0 PLATFORM; Ø3,5; H 4,5MMINTMIP335452026-01-29
08435389829850MULTI-IM ABUTMENT; INTERNA 3.0 PLATFORM; H 4,5MMINTMIP3452026-01-29

Other Devices Sharing Product Codes

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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
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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