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Found 7 results
510(k) Data Aggregation
K Number
K251252Device Name
NOBILCAM IMPAK Disc
Manufacturer
Shandong Huge Dental Material Corporation
Date Cleared
2025-08-01
(100 days)
Product Code
MQC
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Shandong Huge Dental Material Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K220680Device Name
Denture Base Polymers
Manufacturer
Shandong Huge Dental Material Corporation
Date Cleared
2022-08-12
(157 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
Shandong Huge Dental Material Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Denture Base Polymers is used for fabrication and repair of partial and full denture base for patients with missing teeth.
Device Description
Denture Base Polymers contains powder and liquid, wherein the power is mainly composed of polymethyl methacrylate, and the main composition of the liquid is methyl methacrylate.
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K Number
K213994Device Name
Flexible Block
Manufacturer
Shandong Huge Dental Material Corporation
Date Cleared
2022-03-04
(73 days)
Product Code
EBI, MQC
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
Shandong Huge Dental Material Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for making dental plates, bite plates, frame-works, clasps,personal trays, appliances, occlusal splints and night guards.
Device Description
Flexible Block is a circular solid (disc) or rectangular solid (block) made from polyamide through high-temperature injection molding, and is used in a CAD/CAM milling machine for production of dental plates, bite plates, frame-works, clasps, personal trays, appliances, occlusal night guards. These blocks are available in a variety of shapes and sizes for different milling systems and in a variety of dental shades.
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K Number
K201684Device Name
A-Silicone for Bite Registration
Manufacturer
Shandong Huge Dental Material Corporation
Date Cleared
2020-09-24
(94 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
Shandong Huge Dental Material Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A-Silicone for Bite Registration is indicated for making occlusal registrations.
Device Description
A-Silicone for Bite Registration is a vinylpolysiloxane (addition silicone), also known as A-Silicones, polyvinyl siloxanes (PVS), or vinyl polysiloxanes (VPS), especially made for bite registration work in the surgery and laboratory. It mainly contains polydimethylsiloxane, silica and platinum catalyst.
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K Number
K181747Device Name
Orthodontic Appliance
Manufacturer
Shandong Huge Dental Material Corporation
Date Cleared
2019-04-18
(290 days)
Product Code
NXC
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
Shandong Huge Dental Material Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Orthodontic Appliance is indicated for the correction of tooth malocclusion in patients with permanent dentition. The Orthodontic Appliance moves the teeth by continuous gentle force.
Device Description
The Orthodontic Appliance is a series of clear, lightweight, plastic aligners that are used to replace traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligners moves the teeth gently, and in small increments, from their original to their final treated position for improved dental alignment. The product is made of a polymer thermoplastic material (polyvinyl ester mixture) by pressing.
The doctor-prescribed Orthodontic Appliance are provided non-sterile and are customized for each patient according to the 3D printed data designed by Clear Aligner Design Software. Shandong Huge Dental Material Corporation manufactures the Orthodontic Appliance by thermoforming commercially available thermoplastic material and send them to the clinician. The clinician confirms the fit of the aligners upon delivery to the patient and monitors the patient's progress throughout treatment. Depending on the patient need and the treatment plan, a series of aligners may be used. The duration of use for each pair of appliance is 2-3 weeks, wear the appliances for at least 20 hours every day and it is to be worn except during eating or cleaning of the oral cavity.
The type of Orthodontic Appliance is LX-A with various thickness so that the clinician can select suitable thickness based on patients' teeth micromaxillary deformity conditions. Different thickness are identical in chemical compositions, indications for use, functions, performance characteristics, operation principle and other aspects.
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K Number
K160345Device Name
Glass Ionomer Cement
Manufacturer
SHANDONG HUGE DENTAL MATERIAL CORPORATION
Date Cleared
2017-03-03
(389 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
SHANDONG HUGE DENTAL MATERIAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Self-curing glass ionomer based radiopaque filling cement, for dental use only. Recommended Indications:
(1) Restoration of primary teeth.
(2) Restorations of Class III, V and limited Class I cavities.
(3) Base linings under composite and amalgam.
(4) Core build-up.
Device Description
Glass Ionomer Cement (Filling) has two types: Filling II. It is a device composed of various materials including Silica, Alumina, Strontium Fluoride in the powder composition and Poly Carboxylic Acid in the liquid composition which intended to serve as a permanent or temporary tooth filling or as base linings. It's a powder liquid system. The basic operation principle of Glass Ionomer Cement (Filling) is acid-base reaction.
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K Number
K161851Device Name
Glass Ionomer Cement (Luting)
Manufacturer
SHANDONG HUGE DENTAL MATERIAL CORPORATION
Date Cleared
2016-10-31
(117 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
SHANDONG HUGE DENTAL MATERIAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Self-curing glass ionomer based radiopaque luting cement, for dental use only. Recommended indications:
(1) Cementation of metal-based inlays, onlays, crowns and bridges;
- (2) Cementation of high strength (zirconia based) all ceramic crowns and bridges;
- (3) Cementation of posts and screws made of metal or high-strength ceramic;
- (4) Cementation of orthodontic bands;
- (5) Restoration of caries in unstressed area (Luting II only).
Device Description
Glass Ionomer Cement (Luting) has two models: Luting II. It is a device composed of various materials mainly including Silica, Alumina, Strontium Fluoride in the powder composition and Poly Carboxylic Acid in the liquid composition which intended to serve as luting to affix dental devices such as metal-based inlays, onlays, crowns, bridges, and orthodontic bands. It's a powder liquid system, with each part is packaged separately when not in use. The basic operation principle of Glass Ionomer Cement (Luting) is acid-base reaction.
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