FDA.report

GuidedSMILE

Primary DI
00850065193045
Brand
GuidedSMILE
Company
GuidedSMILE LLC
Model
FIX04
Device description
Lite Stacking Pin
Published
2024-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850065193045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850065193045008500651930458500651930450850065193045

GMDN Terms

TermDefinition
Dental implantation drilling template retention pinA small, metal peg designed to provide initial stability to anchor a custom-made surgical template that is fitted over the ridge of existing teeth and/or gum of a patient during the first stage of a dental implantation procedure. It is inserted through lateral guide hole(s) in the template, and is pressed into pre-drilled hole(s) in the jawbone. It is used for implantation procedures where a tooth/teeth are missing and a template is used to provide the dentist with the correct drilling position(s) for the implant(s). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
119282318
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
00850065193083GuidedSMILENBCG2024-07-09
00850065193090GuidedSMILENBGS2024-07-09
00850065193106GuidedSMILESHGP2024-07-09
00850065193007GuidedSMILECLFIX042024-06-25
00850065193014GuidedSMILECLFIX032024-06-25
00850065193021GuidedSMILECLFIX022024-06-25
00850065193038GuidedSMILECLFIX012024-06-25
00850065193052GuidedSMILEFIX012024-06-25
00850065193069GuidedSMILEFIX022024-06-25
00850065193076GuidedSMILEFIX032024-06-25

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Primary DIBrandCompanyProduct codePublished
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08800055792958Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
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08800055792972Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792996Torque RatchetARUM DENTISTRY Co., Ltd.NDP2026-03-24
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