FDA.reportPublic FDA data

CEKA & PRECI-LINE ATTACHMENTS

Primary DI
04260576943989
Brand
CEKA & PRECI-LINE ATTACHMENTS
Company
Alphadent NV
Model
RE H 10
Catalog number
RE H 10
Device description
CARBIDE BURR 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
EIFACCESSORIES, RETRACTOR, DENTAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260576943989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260576943989042605769439894260576943989

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
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
04251436943836KOHLERKohler Medizintechnik GmbHEIF2026-03-12
00840479200040CHEEK RETRACTORRELIANCE ORTHODONTIC PRODUCTS INCEIF2026-02-23
00840479200057CHEEK RETRACTORRELIANCE ORTHODONTIC PRODUCTS INCEIF2026-02-23
00810042124875OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIF2026-01-28
D248938520Uni-Wedge Regular ( Orange)HAGER WORLDWIDE, INC.EIF2026-01-28
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
08800099963857Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963864Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963871Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963888Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963895Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963901Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963918Perfit ZRVatech mcis Co., LtdEIF2025-04-07