FDA.reportPublic FDA data

Flexi-Flange Fiber

Primary DI
00766054001683
Brand
Flexi-Flange Fiber
Company
ESSENTIAL DENTAL SYSTEMS, INC.
Model
2496-00
Catalog number
2496-00
Device description
Flexi-Flange Fiber Depth Gauge
Published
2020-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EILGAUGE, DEPTH, INSTRUMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00766054001683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00766054001683007660540016837660540016830766054001683

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic stopperA device that is used as a measuring reference point on an endodontic instrument used in a root canal procedure. It is typically designed as a flat ring made of an elastic material (e.g., silicone) that is placed at a predetermined distance from the distal end of the instrument (e.g., an endodontic file) allowing the operator to gauge the maximum depth of penetration. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(201)487-9090udi@edsdental.com

Regulatory Flags#

DUNS number
101147171
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00766054002987Turbo-CR1100-301100-302025-04-04
00766054002994Turbo-CR1100-001100-002025-04-04
00766054003007Turbo-CR1100-1001100-1002025-04-04
00766054002949BIOSEAL1640-001640-002024-10-31
00766054002970BIOSEAL1640-151640-152024-10-31
00766054002901Bio-LCB910-02910-022022-10-28
00766054002918Bio-LCB910-03910-032022-10-28
00766054002925Bio-LCB910-50910-502022-10-28
00766054002932Bio-LCB910-01910-012022-10-28
00766054000617Tango-Endo5425-005425-002020-07-17
00766054000624Tango-Endo5421-005421-002020-07-17
00766054000631Tango-Endo5421-025421-022020-07-17
00766054000648Tango-Endo5425-025425-022020-07-17
00766054000655Tango-Endo5421-045421-042020-07-17
00766054000662Tango-Endo5425-045425-042020-07-17
00766054000679Tango-Endo5425-405425-402020-07-17
00766054000686Tango-Endo5425-505425-502020-07-17
00766054000693Tango-Endo5300-005300-002020-07-17
00766054000709Tango-Endo5400-015400-012020-07-17
00766054000716SafeSiders5021-GLP5021-GLP2020-07-17

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Primary DI, Brand, Company table
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00194613114893MSI Precision Specialty InstrumentsMed Saver, Inc.EIL2025-08-01
E8961732150SCHWERTA. Schweickhardt GmbH & Co. KGEIL2025-04-07
EZPF2474408HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEIL2025-03-07
00371347018318Advance Dental ProductsThe Atlanta Dental Supply CompanyEIL2025-01-02
00371347018356Advance Dental ProductsThe Atlanta Dental Supply CompanyEIL2025-01-02
00841336121584Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIL2024-12-11
00190730084682Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
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00190730084859Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
08800016113303Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
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08800016121636Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121643Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121650Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121667Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08