FDA.reportPublic FDA data

Milling Disc

Primary DI
06909412314788
Brand
Milling Disc
Company
SHANDONG HUGE DENTAL MATERIAL CORPORATION
Model
98×20mm/2S/Pink/1×1
Published
2026-10-25
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

Product Codes#

Code, Name table
CodeName
MQCMouthguard, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251252000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251252000NOBILCAM IMPAK DiscShandong Huge Dental Material Corporation2025-08-01MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06909412314788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06909412314788069094123147886909412314788

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Regulatory Flags#

DUNS number
528184691
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06909412314672Milling Disc98×16mm/2S/Clear/1×12026-10-25
06909412314689Milling Disc98×16mm/2S/Pink/1×12026-10-25
06909412314696Milling Disc98×16mm/2S/Red/1×12026-10-25
06909412314702Milling Disc98×16mm/2S/Blue/1×12026-10-25
06909412314719Milling Disc98×16mm/2S/Orange/1×12026-10-25
06909412314726Milling Disc98×18mm/2S/Clear/1×12026-10-25
06909412314733Milling Disc98×18mm/2S/Pink/1×12026-10-25
06909412314740Milling Disc98×18mm/2S/Red/1×12026-10-25
06909412314757Milling Disc98×18mm/2S/Blue/1×12026-10-25
06909412314764Milling Disc98×18mm/2S/Orange/1×12026-10-25
06909412314771Milling Disc98×20mm/2S/Clear/1×12026-10-25
06909412314795Milling Disc98×20mm/2S/Red/1×12026-10-25
06909412314801Milling Disc98×20mm/2S/Blue/1×12026-10-25
06909412314818Milling Disc98×20mm/2S/Orange/1×12026-10-25
06970402677596Denture Base PolymersType 1 class 1(A) Traditional Heat Curing/Powder 12026-10-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06909412314672Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314689Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314696Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314702Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314719Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314726Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314733Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314740Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314757Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314764Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314771Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314795Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314801Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314818Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
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