FDA.report

CEKA & PRECI-LINE ATTACHMENTS

Primary DI
04260576940346
Brand
CEKA & PRECI-LINE ATTACHMENTS
Company
Alphadent NV
Model
1230
Catalog number
1230
Device description
Preci-Ball/ Clix Cup Burr
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

Related Records

Contact Domains

Product Codes

CodeName
EJBHANDLE, INSTRUMENT, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14260576940343PrimaryGS10
04260576940346Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1426057694034314260576940343
04260576940346042605769403464260576940346

GMDN Terms

TermDefinition
Steel dental bur, reusableA rotary cutting device made from high-grade carbon steel with the working end typically formed with cutting planes, e.g., spiralled flutes, 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.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Outer Diameter2.35Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+328004969500info@ckpl.eu

Regulatory Flags

DUNS number
283174985
Device count
2
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 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

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00348783010206Premier Mirror HandlesPREMIER DENTAL PRODUCTS COMPANYEJB2026-03-17
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00841013120459Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EJB2026-01-06
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08057639710598Offset Tip SPMC BIO SRLEJB2025-06-23
08057639710604Long Tip SPMC BIO SRLEJB2025-06-23
08057639710628GBR MODULAR SETMC BIO SRLEJB2025-06-23
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