FDA.reportPublic FDA data

Surgical Guide

Primary DI
06909412328044
Brand
Surgical Guide
Company
SHANDONG HUGE DENTAL MATERIAL CORPORATION
Model
SG 2.0
Catalog number
Clear/1.0 kg/bottle
Published
2026-05-19
Public version status
New
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
06909412328044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06909412328044069094123280446909412328044

GMDN Terms#

Term, Definition table
TermDefinition
Dental guided surgery reference plateA non-sterile device in the form of a plate designed for the fabrication of custom-made scan and surgical dental implant templates used by a dentist during the first stage of a guided dental implantation procedure (i.e., drilling holes in the jawbone for implant placement/fixation). It is a plastic plate of a predefined shape and hole configuration for placement of dental guided surgery reference pins to form a link between a chairside cone beam computerized tomography (CBCT) scan and a coordinate system for dental laboratory fabrication of the scan template (used to scan the patient) and then the surgical dental implant template. This is a single-use device.

Regulatory Flags#

DUNS number
528184691
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06909412319455Dental ModelM 2.01.0 kg/bottle2026-05-19
06909412319929Porcelain PowdersPowderA/10g2026-05-19
06909412319936Porcelain PowdersPowderB/10g2026-05-19
06909412320024Porcelain PowdersBlending LiquidL1/20mL2026-05-19
06909412320031Porcelain PowdersBlending LiquidL2/20mL2026-05-19
06909412320048Porcelain PowdersStain/GlazeA/5g2026-05-19
06909412320055Porcelain PowdersStain/GlazeB/5g2026-05-19
06909412320246Porcelain Powders/K-001-162026-05-19
06909412327825Dental ModelM 3.01.0 kg/bottle2026-05-19
06909412327900Denture BaseDB2S/500 g/bottle2026-05-19
06909412327917Denture BaseDB2S/1.0 kg/bottle2026-05-19
06909412327924Denture BaseDBPink/500 g/bottle2026-05-19
06909412327931Denture BaseDBPink/1.0 kg/bottle2026-05-19
06909412327948Denture BaseDBPink1/500 g/bottle2026-05-19
06909412327955Denture BaseDBPink1/1.0 kg/bottle2026-05-19
06909412327962Denture BaseDBPink2/500 g/bottle2026-05-19
06909412327979Denture BaseDBPink2/1.0 kg/bottle2026-05-19
06909412327986Denture BaseDBPink3/500 g/bottle2026-05-19
06909412327993Denture BaseDBPink3/1.0 kg/bottle2026-05-19
06909412328006Denture BaseDBPink4/500 g/bottle2026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002021Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002038Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002045Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002052Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002069Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002076Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532002397Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14