FDA.reportPublic FDA data

MANI CARBIDE BURS

Primary DI
04546951601461
Brand
MANI CARBIDE BURS
Company
MANI, INC.
Model
1 (CA)
Device description
MANI CARBIDE BURS
Published
2026-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EJLBUR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546951601461PrimaryGS10
74546951601460Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546951601461045469516014614546951601461
7454695160146074546951601460

GMDN Terms#

Term, Definition table
TermDefinition
Carbide dental bur, reusableA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. 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
690622428
Device count
10
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14546951638990MANI Ophthalmic KnifeMSL16MV-02 Slit Angled 1.6mm2026-04-23
14546951618787MANI TRABECULOTOMY HOOKMTH-S TRABECULOTOMY HOOK Straight Type2026-04-29
04546951534219MANI CARBIDE BURS6 (CA)2026-04-08
04546951601447MANI CARBIDE BURS1/4 (CA)2026-04-08
04546951601454MANI CARBIDE BURS1/2 (CA)2026-04-08
04546951601478MANI CARBIDE BURS2 (CA)2026-04-08
04546951601485MANI CARBIDE BURS3 (CA)2026-04-08
04546951601492MANI CARBIDE BURS4 (CA)2026-04-08
04546951601508MANI CARBIDE BURS5 (CA)2026-04-08
04546951601515MANI CARBIDE BURS7 (CA)2026-04-08
04546951601522MANI CARBIDE BURS8 (CA)2026-04-08
04546951400729MANI Sutures Polyester337833782016-06-04
04546951400750MANI Sutures Polyester337533752016-06-04
04546951400767MANI Sutures Polyester337433742016-06-04
04546951400859MANI Sutures Polyester337333732016-06-04
04546951401429MANI Sutures Polyester141214122016-06-04
04546951402662MANI Sutures Polyester337133712016-06-04
04546951402679MANI Sutures Polyester337033702016-06-04
04546951400538MANI Sutures Polyester435743572016-06-04
04546951400705MANI Sutures Polyester338033802016-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ESUNC1623160165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2025-04-29
07630049901384C141 Allport bone cutterDiaswiss SAEJL2023-10-02
07630049901612DIA-ZDiaswiss SAEJL2023-10-02
07630049902077Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951051Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951075Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951532Carbide bur Diacarb FG HCDiaswiss SAEJL2023-10-02
07630049951556FG Diacarb finishing bur HCDiaswiss SAEJL2023-10-02
07630049951921C141 Allport bone cutterDiaswiss SAEJL2023-10-02
07630049951983Carbide bur Diacarb RA HCDiaswiss SAEJL2023-10-02
07630049952003Carbide finishing bur Diacarb RADiaswiss SAEJL2023-10-02
07630049952041FG Diacarb carbide crown cutterDiaswiss SAEJL2023-10-02
07630049952065Carbide bur Diacarb FG HCDiaswiss SAEJL2023-10-02
07630049952089FG Diacarb finishing burDiaswiss SAEJL2023-10-02
07630049952164FG Diacarb finishing burDiaswiss SAEJL2023-10-02
07630049952188FG Diacarb finishing burDiaswiss SAEJL2023-10-02
ESUNC283K3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-25
ESUNC33L3140105Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNC33L3140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040185Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040215Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040235Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040275Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCTR323140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040145Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040215Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040235Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNC463140145Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07