FDA.report

Darby Dental Supply, LLC

Primary DI
00889813065327
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
5257185
Device description
EXCAVATOR 5 DE
Published
2024-11-30
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
false

Related Records

Product Codes

CodeName
EKCEXCAVATOR, DENTAL, OPERATIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EKCExcavator, Dental, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889813065327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813065327008898130653278898130653270889813065327

GMDN Terms

TermDefinition
Dental excavator, reusableA hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
825137818
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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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10889813067809Darby Dental Supply, LLC95531462025-07-02
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10889813067823Darby Dental Supply, LLC95531482025-07-02

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Primary DIBrandCompanyProduct codePublished
00348783008456Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-03-17
00348783008586Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-03-17
00348783008678Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-03-17
00840018674219Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKC2026-02-11
00840018667693Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKC2026-02-10
00840018667709Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKC2026-02-10
00840018666511Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKC2026-02-09
00840018666979Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKC2026-02-09
00840018662575Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKC2026-01-29
00840018661394Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKC2026-01-28
05010058178113InstrapacROBINSON HEALTHCARE LIMITEDEKC2025-06-23
05010058182691InstrapacROBINSON HEALTHCARE LIMITEDEKC2025-06-23
05010058080348InstrapacROBINSON HEALTHCARE LIMITEDEKC2025-06-18
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00889813065402Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-12-18
00889813065358Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-11-30
00889813065365Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-11-30
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00813677024503PDT, Inc.PDT, INC.EKC2024-06-27
00813677024954PDT, Inc.PDT, INC.EKC2024-06-26
00842517109063Karl SchumacherKarl Schumacher Dental, LLCEKC2024-05-06
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