FDA.reportPublic FDA data

CERALOG® PL Screwdriver ISO-shaft, short, L 20.2 mm

Primary DI
07640161397095
Brand
CERALOG® PL Screwdriver ISO-shaft, short, L 20.2 mm
Company
CeramTec Schweiz GmbH
Model
HP5331.0001
Catalog number
HP5331.0001
Device description
Tools
Published
2024-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGSHandpiece, Contra- And Right-Angle Attachment, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640161397095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640161397095076401613970957640161397095

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry, Keep out of sunlight
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+41443883630pascal.wettstein@zeramex.com
+41443883636mpd.regulatory@ceramtec.de

Regulatory Flags#

DUNS number
483229493
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640161391451ZERADRILL™ W12 (WIDE 12mm)T37612T376122018-11-30
07640161391840ZERAMEX® XT Implant Ø5.5x8mm WB (incl. Healing Cap)XT17508XT175082018-11-30
07640161392403ZERAMEX® RB Transfer Closed TrayRB36512RB365122018-11-30
07640161392502ZERAMEX® WB Transfer Closed TrayWB37512WB375122018-11-30
07640161393028NobelPearl 15 Abutment Inter-X WP 1mm3006713006712018-11-30
07640161393134NobelPearl Lab Screw Inter-X RP/WP3006953006952018-11-30
07640161393158NobelPearl Cover Screw Inter-X WP3007013007012018-11-30
07640161393172NobelPearl Healing Abutment Inter-X RP 4.2x4mm3007093007092018-11-30
07640161393196NobelPearl Healing Abutment Inter-X WP 5.5x4mm3007123007122018-11-30
07640161393257NobelPearl Impression Coping Closed Tray Inter-X WP3007213007212018-11-30
07640161393264NobelPearl Impression Coping Closed Tray Inter-X RP long3007233007232018-11-30
07640161393301NobelPearl Implant Replica Inter-X RP3007293007292018-11-30
07640161393325NobelPearl Round Bur 2mm3007313007312018-11-30
07640161393356NobelPearl Tapered Drill NP 3.5x10mm3007343007342018-11-30
07640161393363NobelPearl Tapered Drill NP 3.5x12mm3007353007352018-11-30
07640161393424NobelPearl Tapered Drill RP 4.2x12mm3007423007422018-11-30
07640161393455NobelPearl Tapered Dense Bone Drill RP 4.2mm3007453007452018-11-30
07640161393493NobelPearl Tapered Screw Tap WP 5.5mm3007493007492018-11-30
07640161393523NobelPearl Tapered Depth/Direction Indicators3007513007512018-11-30
07640161393530NobelPearl Screwdriver RP/WP 19mm3006613006612018-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D77142130771Dental CityICP, INC.EGS2026-05-27
D77142131771Dental CityICP, INC.EGS2026-05-27
D77142132771Dental CityICP, INC.EGS2026-05-27
D77142133771Dental CityICP, INC.EGS2026-05-27
10304040196974Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
10304040196981Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
08809260470279TRAUSSaeshin Precision Co., Ltd.EGS2026-03-31
10686864060946MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
10686864060953MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
10686864061141MEDICOM DENTICAREAMD Medicom IncEGS2025-03-18
10686864060915MEDICOM DENTICARE SWIVEL DPA, SOFT CUPAMD Medicom IncEGS2024-09-27
10686864060922MEDICOM DENTICARE SWIVEL DPA, FIRM CUPAMD Medicom IncEGS2024-09-27
10686864060939MEDICOM DENTICARE SWIVEL DPA, TAPERED BRUSHAMD Medicom IncEGS2024-09-27
00302730002911YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002928YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002935YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002942YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002959YoungYOUNG DENTAL MANUFACTURING I, LLCEGS2024-09-19
00302730002997Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003000Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003017Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003024Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003031Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003055Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003062Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003079Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003086Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003093Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003109Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29
00302730003116Henry ScheinYOUNG DENTAL MANUFACTURING I, LLCEGS2024-03-29