FDA.reportPublic FDA data

CEKA & PRECI-LINE ATTACHMENTS

Primary DI
04260576943996
Brand
CEKA & PRECI-LINE ATTACHMENTS
Company
Alphadent NV
Model
RE H 12
Catalog number
RE H 12
Device description
REVAX M2 THREAD-CLEANER 1 P.
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
EIFACCESSORIES, RETRACTOR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260576943996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260576943996042605769439964260576943996

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.

Contacts#

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

Regulatory Flags#

DUNS number
283174985
Device count
1
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
D955RETWIED01Paul BandittTerlain Enterprises, Inc.EIF2026-09-25
00810194403415AiraAIRA, LLCEIF2026-08-26
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08800325901202Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901219Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901226Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901233Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901240Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901257Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901264Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901271Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901288Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901295Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901301Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901318Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901325Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901332Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901349Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901356Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901363Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901370Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901387Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901394Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901400Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901417Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901424Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901431Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901448Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901455Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901462Perfit OneMLVatech mcis Co., LtdEIF2026-07-20