FDA.report

STOPPER PILOT DRILL

Primary DI
08800020818676
Brand
STOPPER PILOT DRILL
Company
SNUCONE Co.,LTD.
Model
SPD1.1-2712
Published
2023-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DZADrill, Dental, Intraoral

Product Code Classifications

CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800020818676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800020818676088000208186768800020818676

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
9999999999snucone@naver.com

Regulatory Flags

DUNS number
688806132
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08800020818898DRILL EXTENSIONDE2023-02-21
08800020818911LINDEMANN DRILLLD-212023-02-21
08800020818928COUNTER SINKCS-352023-02-21
08800020818935COUNTER SINKCS-402023-02-21
08800020818942COUNTER SINKCS-432023-02-21
08800020818959COUNTER SINKCS-482023-02-21
08800020818966COUNTER SINKCS-532023-02-21
08800020818973COUNTER SINKCS-582023-02-21
08800020818980PARALLEL PINPP-02023-02-21
08800020819000GINGIVA GAUGEAGG2023-02-21
08800020819017HANDPIECE HEX DRIVERHDD2023-02-21
08800020819055FIXTURE GRIP DRIVERFBGDAM-M2023-02-21
08800020819062FIXTURE GRIP DRIVERFBGDA-S2023-02-21
08800020819079FIXTURE GRIP DRIVERFBGDA-M2023-02-21
08800020819086FIXTURE GRIP WRENCH DRIVERFBGWAM-S2023-02-21
08800020819093FIXTURE GRIP WRENCH DRIVERFBGWAM-L2023-02-21
08800020819109FIXTURE GRIP WRENCH DRIVERFBGWA-S2023-02-21
08800020819116FIXTURE GRIP WRENCH DRIVERFBGWA-L2023-02-21
08800020819123TORQUE WRENCHTW2023-02-21
08800020819130DEPTH GAUGE WRENCH GUIDE HOLDERDGWGH2023-02-21

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