FDA.reportPublic FDA data

Medentika

Primary DI
04251574863492
Brand
Medentika
Company
MEDENTiKA GmbH
Model
025.0081
Catalog number
025.0081
Device description
Scanbody
Published
2023-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251574863492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251574863492042515748634924251574863492

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment analog, scanningA non-sterile device intended to be used as temporary copy of a dental implant abutment in a patient to confirm the position of the final dental implant body during dental implant restorative procedures. It is used during a scanning procedure, typically performed with a digital intraoral sensor (e.g., via x-ray imaging). It consists of a rod-like device intended to be attached to a dental implant; it is typically made of a radiopaque material (e.g., barium sulfate). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
537555497
Device count
1
Premarket exempt
true
Kit
true
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
04251574845405MEDENTiKAOT 8503OT 85032026-05-13
04251574867803MEDENTiKA6-31-036-31-032026-05-13
04251574853134MEDENTiKAMG 80 TMG 80 T2026-04-21
04251574862228MEDENTiKAL 69-ETL 69-ET2026-02-20
04251574864901MEDENTiKAI 63-ETI 63-ET2026-02-20
04251574866806MEDENTiKAK 65K 652026-02-20
04251574867780MEDENTiKAK 65-ETK 65-ET2026-02-20
04251574867216MEDENTiKAE 9000-ASE 9000-AS2026-02-12
04251574867223MEDENTiKAE 9010-ASE 9010-AS2026-02-12
04251574867230MEDENTiKAE 9020-ASE 9020-AS2026-02-12
04251574867247MEDENTiKAE 9030-ASE 9030-AS2026-02-12
04251574867254MEDENTiKAEV 9000-ASEV 9000-AS2026-02-12
04251574867261MEDENTiKAEV 9010-ASEV 9010-AS2026-02-12
04251574867278MEDENTiKAEV 9020-ASEV 9020-AS2026-02-12
04251574867285MEDENTiKAEV 9030-ASEV 9030-AS2026-02-12
04251574867292MEDENTiKAEV 9040-ASEV 9040-AS2026-02-12
04251574867308MEDENTiKAF 9000-ASF 9000-AS2026-02-12
04251574867315MEDENTiKAF 9010-ASF 9010-AS2026-02-12
04251574867322MEDENTiKAF 9020-ASF 9020-AS2026-02-12
04251574867339MEDENTiKAF 9030-ASF 9030-AS2026-02-12