FDA.reportPublic FDA data

CEKA & PRECI-LINE ATTACHMENTS

Primary DI
14260576942286
Brand
CEKA & PRECI-LINE ATTACHMENTS
Company
Alphadent NV
Model
RE H 2
Catalog number
RE H 2
Device description
REVAX M2 IMPRESSION TOOL 2 PCS
Published
2021-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJBHANDLE, INSTRUMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14260576942286PrimaryGS10
04260576942289Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1426057694228614260576942286
04260576942289042605769422894260576942289

GMDN Terms#

Term, Definition table
TermDefinition
Dental precision attachment fitting/adjustment toolA manual dental laboratory instrument intended to be used in a dental laboratory during fabrication or revision of a final dental prosthesis (e.g., denture, crown, bridge) to integrate and/or adjust the fitting between male and female precision attachments. It is in the form of a handle with a distal end designed to perform a dedicated function (e.g., facilitate the parallel placement of a male attachment, remove/exchange/adjust an attachment, insert a retention insert, tighten a screwable element of an attachment); some types may be heated to enable melting, or attached to a motorized handpiece (e.g., drill). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter2Millimeter

Contacts#

Phone, Email table
PhoneEmail
+328004969500info@ckpl.eu

Regulatory Flags#

DUNS number
283174985
Device count
2
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260576941503CEKA & PRECI-LINE ATTACHMENTS6700B6700B2021-03-30
04260576941510CEKA & PRECI-LINE ATTACHMENTS6701B6701B2021-03-30
04260576941527CEKA & PRECI-LINE ATTACHMENTS6702B6702B2021-03-30
04260576941541CEKA & PRECI-LINE ATTACHMENTS6711B6711B2021-03-30
04260576941725CEKA & PRECI-LINE ATTACHMENTSCEKA SITE BCEKA SITE B2021-03-30
04260576940537CEKA & PRECI-LINE ATTACHMENTS1291 C1291 C2021-05-04
04260576940551CEKA & PRECI-LINE ATTACHMENTS1293 C1293 C2021-05-04
14260576940244CEKA & PRECI-LINE ATTACHMENTS1205 CB1205 CB2021-04-20
14260576940350CEKA & PRECI-LINE ATTACHMENTS123112312021-04-20
14260576940367CEKA & PRECI-LINE ATTACHMENTS1231B1231B2021-04-20
14260576940374CEKA & PRECI-LINE ATTACHMENTS123212322021-04-20
14260576940381CEKA & PRECI-LINE ATTACHMENTS1232B1232B2021-04-20
14260576940398CEKA & PRECI-LINE ATTACHMENTS123312332021-04-20
14260576940411CEKA & PRECI-LINE ATTACHMENTS123512352021-04-20
14260576940428CEKA & PRECI-LINE ATTACHMENTS1235B1235B2021-04-20
14260576940435CEKA & PRECI-LINE ATTACHMENTS123612362021-04-20
14260576940466CEKA & PRECI-LINE ATTACHMENTS1251 B1251 B2021-04-20
14260576940688CEKA & PRECI-LINE ATTACHMENTS131613162021-04-20
14260576940695CEKA & PRECI-LINE ATTACHMENTS1316B1316B2021-04-20
14260576940701CEKA & PRECI-LINE ATTACHMENTS132113212021-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08961104622142Strip PlacerMELPEX BEAUTY INSTRUMENTSEJB2026-05-21
G149TBSB3100TBS BASICSACME ENTERPRISE.EJB2026-05-16
08809260472853TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472860TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472877TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472884TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472891TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472907TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472914TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472921TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
G149NP360100NPSACME ENTERPRISE.EJB2026-05-01
G149NP380630NPSACME ENTERPRISE.EJB2026-05-01
EZPF26179500HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179510HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179550HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179560HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179570HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179580HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179590HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
10371347017721Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
10371347017745Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
08800075626905OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627230OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627247OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627254OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627674OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627681OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627735OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627742OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627759OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03