MOR Twist Drill, 1.2mm

Primary DI
00841549114755
Brand
MOR Twist Drill, 1.2mm
Company
STERNGOLD DENTAL LLC
Model
905268
Device description
A sterile shaft of metal (a drill bit) 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. It is typically made of a highgrade stainless steel alloy. 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 that is intended, in terms of sterility, for a single patient use.
Published
2016-03-10
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153173000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153173000MOR Implant SystemSterngold Dental, LLC2016-02-05DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841549114755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841549114755008415491147558415491147550841549114755

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
401-871-3489maria.rao@sterngold.com

Regulatory Flags#

DUNS number
124763728
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
00841549118517SternTek Duplicating Material2220122023-10-04
00841549101823ERA® DO LP Basic Kit w/ Tools SS 8114122020-07-07
00841549115042Sterngold Implant System Cortical Bone Drill 3.2mm 9055222020-07-07
00841549103841ERA® Implant Abutment Micro 0°, 4mm Cuff (AX)8124352017-03-21
00841549103889ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (BD)8125322017-03-21
00841549103896ERA® Implant Abutment Micro Ang. Base, 3mm Cuff (BD)8125332017-03-21
00841549103902ERA® Implant Abutment Micro Ang. Base, 4mm Cuff (BD)8125342017-03-21
00841549103919ERA® Implant Abutment Micro Ang. Base, 5mm Cuff (BD)8125352017-03-21
00841549103926ERA® Implant Abutment Micro Ang. Base, 6mm Cuff (BD)8125362017-03-21
00841549103933ERA® Implant Abutment Micro 0°, 0.5mm Cuff (BD)8125372017-03-21
00841549103940ERA® Implant Abutment Micro 0°, 2mm Cuff (BD)8125382017-03-21
00841549103957ERA® Implant Abutment Micro 0°, 3mm Cuff (BD)8125392017-03-21
00841549103964ERA® Implant Abutment Micro 0°, 4mm Cuff (BD)8125402017-03-21
00841549103988ERA® Implant Abutment Micro 0°, 6mm Cuff (BD)8125422017-03-22
00841549103995ERA® Implant Abutment Micro Ang. Base, 1mm Cuff (BE)8125432017-03-22
00841549104008ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (BE)8125442017-03-22
00841549104015ERA® Implant Abutment Micro Ang. Base, 3mm Cuff (BE)8125452017-03-22
00841549104022ERA® Implant Abutment Micro Ang. Base, 4mm Cuff (BE)8125462017-03-22
00841549104039ERA® Implant Abutment Micro Ang. Base, 5mm Cuff (BE)8125472017-03-22
00841549104046ERA® Implant Abutment Micro Ang. Base, 6mm Cuff (BE)8125482017-03-22

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