FDA.reportPublic FDA data

CEKA & PRECI-LINE ATTACHMENTS

Primary DI
04260576943255
Brand
CEKA & PRECI-LINE ATTACHMENTS
Company
Alphadent NV
Model
2954D
Catalog number
2954D
Device description
PRECI-POST CC REAMER D 1 P.
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
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260576943255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260576943255042605769432554260576943255

GMDN Terms#

Term, Definition table
TermDefinition
Root canal post, preformedA prefabricated endodontic rod designed for insertion into the root canal of a patient to support and retain a crown prosthesis. It is typically a solid, cylindrical, metal (e.g., stainless steel, gold alloy) piece with a proximal end appropriate to support the crown on top; it is, however, available in a variety of shapes, dimensions, and materials (e.g., ceramics, fibre-reinforced polymers). In addition, it is available in a variety of types (e.g., non-threaded, pre-threaded, or self-tapping; straight or tapered). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0.8Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
283174985
Device count
1
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
04260576940537CEKA & PRECI-LINE ATTACHMENTS1291 C1291 C2021-05-04
04260576940551CEKA & PRECI-LINE ATTACHMENTS1293 C1293 C2021-05-04
04260576940049CEKA & PRECI-LINE ATTACHMENTS1100 P1100 P2021-03-30
04260576940056CEKA & PRECI-LINE ATTACHMENTS1100/H/MR/OR1100/H/MR/OR2021-03-30
04260576940063CEKA & PRECI-LINE ATTACHMENTS1100/H/MR/PA1100/H/MR/PA2021-03-30
04260576940070CEKA & PRECI-LINE ATTACHMENTS1100/H/MR/IN1100/H/MR/IN2021-03-30
04260576940087CEKA & PRECI-LINE ATTACHMENTS1102/H/MR/OR1102/H/MR/OR2021-03-30
04260576940094CEKA & PRECI-LINE ATTACHMENTS1102/H/MR/PA1102/H/MR/PA2021-03-30
04260576940100CEKA & PRECI-LINE ATTACHMENTS1102/H/MR/IN1102/H/MR/IN2021-03-30
04260576940117CEKA & PRECI-LINE ATTACHMENTS110511052021-03-30
04260576940124CEKA & PRECI-LINE ATTACHMENTS1105AB1105AB2021-03-30
04260576940131CEKA & PRECI-LINE ATTACHMENTS110611062021-03-30
04260576940148CEKA & PRECI-LINE ATTACHMENTS1106AB1106AB2021-03-30
04260576940155CEKA & PRECI-LINE ATTACHMENTS112511252021-03-30
04260576940162CEKA & PRECI-LINE ATTACHMENTS112611262021-03-30
04260576940193CEKA & PRECI-LINE ATTACHMENTS1201 D1201 D2021-03-30
04260576940209CEKA & PRECI-LINE ATTACHMENTS1201 P1201 P2021-03-30
04260576940261CEKA & PRECI-LINE ATTACHMENTS1211 P1211 P2021-03-30
04260576940278CEKA & PRECI-LINE ATTACHMENTS122012202021-03-30
04260576940285CEKA & PRECI-LINE ATTACHMENTS122112212021-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800341415158First DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415165Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415172Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415189Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415196Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415202Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415219Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415226Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415233Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415240Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415257Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415264Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415271Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800055792163Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792170Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792187Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792194Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792200Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792217Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792224Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792231Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792248Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792255Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792262Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792279Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792286Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792293Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792309Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792316Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792323Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20