FDA.reportPublic FDA data

NIC or SUPERLINE

Primary DI
06944835190007
Brand
NIC or SUPERLINE
Company
Shenzhen Superline Technology Co., Ltd.
Model
Round
Device description
Intended useThe product is used with dental motors, it is intended for cutting, trim and finish natural and engineered dental materials during various dental procedures.
Published
2025-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
DZPInstrument, Diamond, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944835190007PrimaryGS10
06944835190014Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944835190007069448351900076944835190007
06944835190014069448351900146944835190014

GMDN Terms#

Term, Definition table
TermDefinition
Diamond dental bur, reusableA rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
527943851
Device count
10
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06944835130195NIC/SUPERLINEAlpha Endo2025-12-22
06944835190366NIC or SUPERLINEDiabolo Amalgam Remover2025-09-18
06944835190410NIC or SUPERLINE Barrel 2025-09-18
06944835190496NIC or SUPERLINEDonut2025-09-18
06944835190571NIC or SUPERLINECylinder Flat End2025-09-18
06944835190816NIC or SUPERLINECylinder Beveled End2025-09-18
06944835190281NIC or SUPERLINEInverted Cone 2025-09-18
06944835190373NIC or SUPERLINEDiabolo Amalgam Remover2025-09-18
06944835190427NIC or SUPERLINE Barrel 2025-09-18
06944835190502NIC or SUPERLINEDonut2025-09-18
06944835190588NIC or SUPERLINECylinder Flat End2025-09-18
06944835190823NIC or SUPERLINECylinder Beveled End2025-09-18
06944835190014NIC or SUPERLINERound2025-09-17
06944835199918NIC or SUPERLINEAlpha Apex I2025-04-28
01069448351999NIC or SUPERLINEAlpha Apex I2025-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630243660995Alpen DiamondsDent4You AGDZP2026-09-04
07630243661237Alpen DiamondsDent4You AGDZP2026-09-04
07630243662470Alpen DiamondsDent4You AGDZP2026-09-04
07630243662494Alpen DiamondsDent4You AGDZP2026-09-04
07630243662517Alpen DiamondsDent4You AGDZP2026-09-04
07630243662531Alpen DiamondsDent4You AGDZP2026-09-04
07630243662555Alpen DiamondsDent4You AGDZP2026-09-04
07630243662579Alpen DiamondsDent4You AGDZP2026-09-04
07630243662593Alpen DiamondsDent4You AGDZP2026-09-04
07630243662616Alpen DiamondsDent4You AGDZP2026-09-04
07630243662630Alpen DiamondsDent4You AGDZP2026-09-04
07630243662654Alpen DiamondsDent4You AGDZP2026-09-04
07630243662678Alpen DiamondsDent4You AGDZP2026-09-04
07630243662692Alpen DiamondsDent4You AGDZP2026-09-04
07630243662715Alpen DiamondsDent4You AGDZP2026-09-04
07630243662739Alpen DiamondsDent4You AGDZP2026-09-04
07630243662753Alpen DiamondsDent4You AGDZP2026-09-04
07630243662777Alpen DiamondsDent4You AGDZP2026-09-04
07630243662791Alpen DiamondsDent4You AGDZP2026-09-04
07630243662814Alpen DiamondsDent4You AGDZP2026-09-04
07630243662838Alpen DiamondsDent4You AGDZP2026-09-04
07630243662852Alpen DiamondsDent4You AGDZP2026-09-04
07630243662876Alpen DiamondsDent4You AGDZP2026-09-04
07630243662890Alpen DiamondsDent4You AGDZP2026-09-04
07630243662913Alpen DiamondsDent4You AGDZP2026-09-04
07630243662937Alpen DiamondsDent4You AGDZP2026-09-04
07630243662951Alpen DiamondsDent4You AGDZP2026-09-04
07630243662975Alpen DiamondsDent4You AGDZP2026-09-04
07630243662999Alpen DiamondsDent4You AGDZP2026-09-04
07630243663019Alpen DiamondsDent4You AGDZP2026-09-04