FDA.report

SAFCO

Primary DI
00840018600652
Brand
SAFCO
Company
NORDENT MANUFACTURING INC
Model
102-9857
Device description
Safco Explorer, 3
Published
2020-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EKBExplorer, Operative

Product Code Classifications

CodeDeviceSpecialtyClass
EKBExplorer, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840018600652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840018600652008400186006528400186006520840018600652

GMDN Terms

TermDefinition
Dental explorerA hand-held manual dental instrument designed for tactile examination (i.e., exploration) in the oral cavity, on the tooth surface and/or gums, mainly to find indentations (e.g., pits, fissures) for the determination of early tooth decay on the crown of teeth; it is also used in periodontology (e.g., to locate subgingival deposits before scaling). It is a long, slender instrument (a manual probe) with a stem that terminates in a thin working part at the distal end which may be needle-like, hooked, or blunt according to the intended use. This is a reusable device.

Sterilization Methods

Method
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
053187985
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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00840018674424Nordent Manufacturing, Inc. OPGN4Nordent Hygiene Catalogue2026-03-12
00840018674431Nordent Manufacturing, Inc. OPGN5-48Nordent Hygiene Catalogue2026-03-12
00840018674455Nordent Manufacturing, Inc. OPGNE128-128Nordent Hygiene Catalogue2026-03-12
00840018674462Nordent Manufacturing, Inc. OPGNMJNordent Hygiene Catalogue2026-03-12
00840018674479Nordent Manufacturing, Inc. OPGNMJTNordent Hygiene Catalogue2026-03-12
00840018674493Nordent Manufacturing, Inc. OPPM17S-18SNordent Hygiene Catalogue2026-03-12
00840018674509Nordent Manufacturing, Inc. OPPLN3-4MMNordent Hygiene Catalogue2026-03-12
00840018674516Nordent Manufacturing, Inc. PC11Q/6Nordent Instruments-Diagnostic2026-03-12
00840018674523Nordent Manufacturing, Inc. CV110/BG6Nordent Hygiene Catalogue2026-03-12
00840018674295Nordent Manufacturing, Inc. OPGGR11-12LNordent Hygiene Catalogue2026-03-11
00840018674301Nordent Manufacturing, Inc. OPGGR1-2Nordent Hygiene Catalogue2026-03-11
00840018674318Nordent Manufacturing, Inc. OPGGR1-2LNordent Hygiene Catalogue2026-03-11
00840018674325Nordent Manufacturing, Inc. OPGGR13-14Nordent Hygiene Catalogue2026-03-11
00840018674332Nordent Manufacturing, Inc. OPGGR13-14LNordent Hygiene Catalogue2026-03-11
00840018674349Nordent Manufacturing, Inc. OPGGR15-16Nordent Hygiene Catalogue2026-03-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00348783005929Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783005974Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783005998Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783006018Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783006056Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783006063Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783006186Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783006223Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
G149TBSEXP111201TBS DentalACME ENTERPRISE.EKB2026-03-02
00840018673229Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-11
00840018674127Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-11
00840018667150Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-10
00840018666108Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-09
00840018663688Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-04
00840018664012Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-04
08800019151548Endodontic ExplorerB& L Biotech, inc.EKB2025-04-30
EZPF2474460HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEKB2025-03-07
EZPF2474465HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEKB2025-03-07
00889813065242Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-12-18
00889813065303Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-12-18
00889813065143Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-12-12
00889813065266Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-12-12
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00889813065181Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30
00889813065198Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30
00889813065204Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30
00889813065228Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30
00889813065235Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30