FDA.reportPublic FDA data

Neoss Implant System

Primary DI
05060440332180
Brand
Neoss Implant System
Company
Neoss Ltd
Model
41189
Catalog number
41189
Device description
Twist Drill Ø4.4 - Short 7-13mm
Published
2015-10-01
Public version status
Update
Distribution status
Not 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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

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
05060440332180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060440332180050604403321805060440332180

GMDN Terms#

Term, Definition table
TermDefinition
Fixture/appliance dental drill bit, single-useA sterile shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a motorized handpiece or other power source that provides rotation. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
216693627
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
05060440333774Neoss Implant SystemIndividual Abutment, Ti, SSC 2023-12-22
05060440333781Neoss Implant SystemIndividual Abutment, Ti, ASC2023-12-22
05060440335860Neoss Implant SystemBridge Ti2023-12-22
05060440335877Neoss Implant SystemBar Ti2023-12-22
05060440336669Neoss Implant SystemDolder Bar Ti2023-12-22
05060440331022Neoss Implant System31144311442015-05-22
05060440331039Neoss Implant System31150311502015-05-22
05060440331718Neoss Implant System41119411192015-10-05
05060440331732Neoss Implant System41124411242015-10-01
05060440332142Neoss Implant System41185411852015-10-01
05060440332159Neoss Implant System41186411862015-10-01
05060440332166Neoss Implant System41187411872015-10-01
05060440332173Neoss Implant System41188411882015-10-01
05060440332197Neoss Implant System41190411902015-10-01
05060440332210Neoss Implant System41197411972015-10-01
05060440332685Neoss Implant System51153511532015-10-08
05060440332845Neoss Implant System64032640322015-10-05
05060440330643Neoss Implant System31270312702015-05-22
05060440330650Neoss Implant System31271312712015-05-22
05060440330667Neoss Implant System31272312722015-05-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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