FDA.reportPublic FDA data

OPTIMUM

Primary DI
00366975026804
Brand
OPTIMUM
Company
BENCO DENTAL SUPPLY CO.
Model
4776-441
Published
2022-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00366975026804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00366975026804003669750268043669750268040366975026804

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

Regulatory Flags#

DUNS number
015108087
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00366975013347FAS-TRACT4006-9062018-12-05
00366975001887BENCO3630-3312016-09-23
D74451864890BENCO5186-4892017-11-29
D74451864980BENCO5186-4982017-11-29
D74451865230BENCO5186-5232017-11-29
D74451865320BENCO5186-5322017-11-29
D74451865410BENCO5186-5412017-11-29
00366975001894BENCO3630-3682016-09-23
00366975001900BENCO3630-3862016-09-23
00366975001917BENCO3630-4022016-09-23
00366975032768BENCO3630-0552016-09-23
00366975070005Sterling5259-5162025-02-26
00366975069993Sterling6694-6422025-02-26
00366975058768BENCO5726-5832022-08-04
00366975003317BENCO3470-4242016-09-23
00366975003409BENCO3470-4152016-09-23
D744101162914Gibson Healthcare1011-6291011-6292015-10-22
D744101164714Gibson Healthcare1011-6471011-6472015-10-22
D74417597511Gibson Healthcare175975117597512017-02-13
D74419672861Gibson Healthcare1967-2861967-2862017-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ESUN379P3140215Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2025-04-29
ESUN801C2040235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2025-04-29
ESUN801F3140185Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801F3140235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801F3140255Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801L3140145Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801L3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801L3140185Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801L3140235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801LC3140145Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801LC3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801LC3140185Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801LC3140235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801SC3140125Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801SC3140145Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801SC3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801SC3140185Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801SC3140235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801SC3140255Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801UF3140105Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801UF3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801UF3140255Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140105Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140125Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140145Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140185Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140215Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140255Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23