FDA.reportPublic FDA data

Neoss Implant System

Primary DI
05060440332104
Brand
Neoss Implant System
Company
Neoss AB
Model
41180
Catalog number
41180
Device description
Countersink, Tapered Ø4.5 mm
Published
2015-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZADrill, Dental, Intraoral
DZIDrill, Bone, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1
DZIDrill, Bone, PoweredDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083561000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083561000NEOSS PROACTIVE IMPLANTNeoss, Ltd.2009-02-11DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060440334528Direct MarkingGS10
05060440332104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060440334528050604403345285060440334528
05060440332104050604403321045060440332104

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
509583543
Device count
1
Lot or batch
true
Manufacturing date on label
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
Primary DIBrandCompanyProduct codePublished
07290108819120Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819137Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819144Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819151Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819168Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819175Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150147EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150178EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150185EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150192EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150208EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150215EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150222EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150239EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150246EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150253EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150260EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150277EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116155623Diamond BurrNORIS MEDICAL LTDDZA2026-08-17
00840456224496JMUJMU DENTAL, INCDZA2026-07-29
00840456224502JMUJMU DENTAL, INCDZA2026-07-29
00840456224519JMUJMU DENTAL, INCDZA2026-07-29
00840456224526JMUJMU DENTAL, INCDZA2026-07-29
00840456224533JMUJMU DENTAL, INCDZA2026-07-29
00840456224540JMUJMU DENTAL, INCDZA2026-07-29
00840456224557JMUJMU DENTAL, INCDZA2026-07-29
00840456224564JMUJMU DENTAL, INCDZA2026-07-29
08806343926302Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926319Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926326Sinus KitShinhung MST Co., Ltd.DZA2026-07-29