FDA.reportPublic FDA data

CEKA & PRECI-LINE ATTACHMENTS

Primary DI
04260576943118
Brand
CEKA & PRECI-LINE ATTACHMENTS
Company
Alphadent NV
Model
1705B
Catalog number
1705B
Device description
PRECI-HORIX INSERTION TOOL 50 PCS
Published
2021-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

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
14260576943115PrimaryGS10
04260576943118Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1426057694311514260576943115
04260576943118042605769431184260576943118

GMDN Terms#

Term, Definition table
TermDefinition
Diamond dental bur, reusableA rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
283174985
Device count
50
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
D955MHERCS1Paul BandittTerlain Enterprises, Inc.EJB2026-09-25
D955MHM10CS1Paul BandittTerlain Enterprises, Inc.EJB2026-09-25
D955MHOCTCS1Paul BandittTerlain Enterprises, Inc.EJB2026-09-25
G8791020130DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJB2026-08-14
G87910201330DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJB2026-08-14
G87910201510DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJB2026-08-14
G8791020160DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJB2026-08-14
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