FDA.reportPublic FDA data

OPTIMUM

Primary DI
00366975064837
Brand
OPTIMUM
Company
BENCO DENTAL SUPPLY CO.
Model
5906-094
Device description
OPT PASTE FILL #2 21MM PK4
Published
2023-01-12
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
EKSFile, Pulp Canal, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00366975064837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00366975064837003669750648373669750648370366975064837

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic obturation material distribution endpiece, reusableA dental endpiece designed to be attached to a dental power tool handpiece to distribute root canal sealer/cement/paste evenly throughout the root canal system typically by applying the material in a lateral direction. It is a thin metal rod with a spiral (e.g., Lentulo spiral type), helicoidal, or circular design. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
015108087
Device count
1
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
00366975012463GIBSON HEALTHCARE5250-9802018-05-31
00366975012470GIBSON HEALTHCARE5250-9992018-05-31
00366975012487GIBSON HEALTHCARE5251-0142018-05-31
00366975012494GIBSON HEALTHCARE5251-0232018-05-31
00366975012500GIBSON HEALTHCARE5251-0322018-06-04
00366975012517GIBSON HEALTHCARE5251-0412018-06-04
00366975012524GIBSON HEALTHCARE5251-0502018-06-04
00366975012531GIBSON HEALTHCARE5251-0692018-06-04
00366975012548GIBSON HEALTHCARE5251-1032018-06-04
00366975012555GIBSON HEALTHCARE5251-1122018-06-04
00366975012562GIBSON HEALTHCARE5251-1212018-06-04
00366975012678GIBSON HEALTHCARE5251-0782018-06-04
00366975012685GIBSON HEALTHCARE5251-0872018-06-04
00366975012692GIBSON HEALTHCARE5251-0962018-06-04
00366975012708GIBSON HEALTHCARE5251-1302018-06-04
00366975072108Sterling6904-7452026-08-27
00366975072115Sterling6904-7542026-08-27
00366975065506Natural Extensions5955-488N35PNK2026-07-30
00366975065513Natural Extensions5955-497N35PNK2026-07-30
00366975065520Natural Extensions5955-504N35PNK2026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640452460194Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460200Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460217Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460224Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460231Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460248Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460255Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460262Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460279Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460286Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460293Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460309Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460316Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460323Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460330Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460347Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460354Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460361Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460378Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460385Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460392Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460408Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460415Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460422Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460439Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460446Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460453Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460460Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460477Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460484Edge EvolveFKG Dentaire SàrlEKS2026-10-27