FDA.reportPublic FDA data

Neoss Implant System

Primary DI
05060440334368
Brand
Neoss Implant System
Company
Neoss AB
Model
41210
Catalog number
41210
Device description
Countersink Edge Ø3.5
Published
2019-11-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZIDrill, Bone, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060440334405Direct MarkingGS10
05060440334368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060440334405050604403344055060440334405
05060440334368050604403343685060440334368

GMDN Terms#

Term, Definition table
TermDefinition
Surgical countersink, reusableA rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
999-999-9999contact.usa@neoss.com

Regulatory Flags#

DUNS number
509583543
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060440335532Neoss Implant System64080640802023-02-13
05060440335549Neoss Implant System64081640812023-02-13
05060440335556Neoss Implant System64082640822023-02-13
05060440335563Neoss Implant System64083640832023-02-13
05060440334283Neoss Implant System64036640362020-11-27
05060440334290Neoss Implant System64037640372020-11-27
05060967630226Yomi One Implant System54001540012024-02-15
05060967630233Yomi One Implant System54002540022024-02-15
05060967630004Yomi One Implant System24008240082024-02-15
05060967630011Yomi One Implant System24009240092024-02-15
05060967630028Yomi One Implant System24010240102024-02-15
05060967630035Yomi One Implant System24011240112024-02-15
05060967630042Yomi One Implant System24012240122024-02-15
05060967630059Yomi One Implant System24014240142024-02-15
05060967630066Yomi One Implant System24015240152024-02-15
05060967630073Yomi One Implant System24016240162024-02-15
05060967630080Yomi One Implant System24017240172024-02-15
05060967630097Yomi One Implant System24018240182024-02-15
05060967630103Yomi One Implant System24020240202024-02-15
05060967630110Yomi One Implant System24021240212024-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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J021304970001Foot control S-N3W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021305040001Implantmed Plus II (SI-2100)W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021305050001Implantmed Plus II (SI-2101)W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021305060001Implantmed Plus II (SI-2102)W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021305070001Piezomed Module Plus II (SP-210 M)W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
07613327652703N/ASTRYKER CORPORATIONDZI2026-04-15
07613327652697N/ASTRYKER CORPORATIONDZI2026-04-13
07613327652710PROstepSTRYKER CORPORATIONDZI2026-04-13
07613327652727N/ASTRYKER CORPORATIONDZI2026-04-13
07613327652734N/ASTRYKER CORPORATIONDZI2026-04-13
07613327654127TPXSTRYKER CORPORATIONDZI2026-04-13
04589551386758VA-SG-TIP HOLDERNAKANISHI INC.DZI2026-04-08
07613327652741N/ASTRYKER CORPORATIONDZI2026-03-25
07613327652758N/ASTRYKER CORPORATIONDZI2026-03-25
J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHDZI2025-12-18
J021303870021SpeedControl SC1 (M-UK1023)W & H Dentalwerk Bürmoos GmbHDZI2023-10-12
J021303880021SpeedControl SC1 (M-UK1015)W & H Dentalwerk Bürmoos GmbHDZI2023-10-12
J021079971101"Instrument Set ""Implant/Crestal P"""W & H Dentalwerk Bürmoos GmbHDZI2023-04-04
J021077856001Instrument Z25PW & H Dentalwerk Bürmoos GmbHDZI2023-04-04
J021303920001Handpiece SA-40 L with cable 1.8 mW & H Dentalwerk Bürmoos GmbHDZI2022-10-19
J021303920011Handpiece SA-40 L with cable 3.5 mW & H Dentalwerk Bürmoos GmbHDZI2022-10-19
J021303870001AMADEO M-UK1023W & H Dentalwerk Bürmoos GmbHDZI2022-08-23
J021300320031WS-75 LGW & H Dentalwerk Bürmoos GmbHDZI2022-06-23
J021300530021S-9W & H Dentalwerk Bürmoos GmbHDZI2022-06-23
J021300560021S-11W & H Dentalwerk Bürmoos GmbHDZI2022-06-23
J021300590011S-10W & H Dentalwerk Bürmoos GmbHDZI2022-06-23
J021300600011S-15W & H Dentalwerk Bürmoos GmbHDZI2022-06-23
J021300610011S-12W & H Dentalwerk Bürmoos GmbHDZI2022-06-23
J021300650021WS-75W & H Dentalwerk Bürmoos GmbHDZI2022-06-23