FDA.reportPublic FDA data

Stopper Drill

Primary DI
08806388237494
Brand
Stopper Drill
Company
Megagen Implant Co. Ltd
Model
TANFSS4313
Catalog number
TANFSS4313
Device description
AnyRidge Internal Ø4.3/ L=13/ Straight
Published
2015-06-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806388237494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806388237494088063882374948806388237494

GMDN Terms#

Term, Definition table
TermDefinition
Fixture/appliance dental drill bit, reusableA 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 manual or power tool handpiece that provides rotation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
687388178
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806388277483Healing AbutmentAOHS50652NAOHS50652NT2023-06-08
08806388286973Healing AbutmentAOHM60907AOHM60907T2023-06-08
08806388286980Healing AbutmentAOHM70802AOHM70802T2023-06-08
08806388286997Healing AbutmentAOHM70803AOHM70803T2023-06-08
08806388287000Healing AbutmentAOHM70804AOHM70804T2023-06-08
08806388287017Healing AbutmentAOHM70805AOHM70805T2023-06-08
08806388287024Healing AbutmentAOHM70807AOHM70807T2023-06-08
08806388287031Healing AbutmentAOHM70902AOHM70902T2023-06-08
08806388287048Healing AbutmentAOHM70903AOHM70903T2023-06-08
08806388287055Healing AbutmentAOHM70904AOHM70904T2023-06-08
08806388287062Healing AbutmentAOHM70905AOHM70905T2023-06-08
08806388287079Healing AbutmentAOHM70907AOHM70907T2023-06-08
08806388287086Healing AbutmentAOHM70102AOHM70102T2023-06-08
08806388287093Healing AbutmentAOHM70103AOHM70103T2023-06-08
0880638828710908806388287109AOHM70104AOHM70104T2023-06-08
08806388287116Healing AbutmentAOHM70105AOHM70105T2023-06-08
08806388287123Healing AbutmentAOHM70107AOHM70107T2023-06-08
08806388287130Healing AbutmentAOHM80902AOHM80902T2023-06-08
08806388287147Healing AbutmentAOHM80903AOHM80903T2023-06-08
08806388287154Healing AbutmentAOHM80904AOHM80904T2023-06-08

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Primary DI, Brand, Company table
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