FDA.reportPublic FDA data

CEKA & PRECI-LINE ATTACHMENTS

Primary DI
14260576943498
Brand
CEKA & PRECI-LINE ATTACHMENTS
Company
Alphadent NV
Model
H 4
Catalog number
H 4
Device description
M3 SOLDERING ACCESSORY AXIAL 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
EIFACCESSORIES, RETRACTOR, DENTAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14260576943498PrimaryGS10
04260576943491Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1426057694349814260576943498
04260576943491042605769434914260576943491

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
Outer Diameter3Millimeter

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
04251436943836KOHLERKohler Medizintechnik GmbHEIF2026-03-12
00840479200040CHEEK RETRACTORRELIANCE ORTHODONTIC PRODUCTS INCEIF2026-02-23
00840479200057CHEEK RETRACTORRELIANCE ORTHODONTIC PRODUCTS INCEIF2026-02-23
D248938521Uni-Wedge Regular ( Orange)HAGER WORLDWIDE, INC.EIF2026-01-28
00810042124875OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIF2026-01-28
D248938520Uni-Wedge Regular ( Orange)HAGER WORLDWIDE, INC.EIF2026-01-28
D2486054610Spandex Advanced Junior (Pink)HAGER WORLDWIDE, INC.EIF2025-10-22
D2486054620Spandex Advanced Large ( Pink)HAGER WORLDWIDE, INC.EIF2025-10-22
07630716603658Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603665Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603672Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603689Geistlich PanoramaDSSM AGEIF2025-09-17
07630716617037Geistlich PanoramaDSSM AGEIF2025-09-17
07630716616382Geistlich PanoramaDSSM AGEIF2025-09-17
07630716616399Geistlich PanoramaDSSM AGEIF2025-09-17
07630716617051Geistlich PanoramaDSSM AGEIF2025-09-17
00840456215074JMUJMU DENTAL, INCEIF2025-07-15
00860013984601TissuePro™ Distal Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984618TissuePro™ Proximal Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984625TissuePro™ Single Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984632TissuePro™ Distal Sleeve, MN Retractor Single-UseArmor Dental Corp.EIF2025-05-12
08800099963765Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963772Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963789Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963796Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963802Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963819Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963826Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963833Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963840Perfit ZRVatech mcis Co., LtdEIF2025-04-07