FDA.reportPublic FDA data

PRODONT-HOLLIGER

Primary DI
03665224021636
Brand
PRODONT-HOLLIGER
Company
PRODONT-HOLLIGER
Model
165.02SI
Catalog number
165.02SI
Device description
excavator dble n° 2 bliss
Published
2021-11-19
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

Product Codes#

Code, Name table
CodeName
EKCExcavator, Dental, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKCExcavator, Dental, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03665224021636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665224021636036652240216363665224021636

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
275499887
Device count
1
DM exempt
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03665224000068PRODONT-HOLLIGERMZP511MZP5112021-11-19
03665224000099PRODONT-HOLLIGERMZP521MZP5212021-11-19
03665224000129PRODONT-HOLLIGERMZP531MZP5312021-11-19
03665224000150PRODONT-HOLLIGERMZP541MZP5412021-11-19
03665224000181PRODONT-HOLLIGERMZP551MZP5512021-11-19
03665224000662PRODONT-HOLLIGER1290.011290.012021-11-19
03665224000679PRODONT-HOLLIGER1290.021290.022021-11-19
03665224000686PRODONT-HOLLIGER1290.041290.042021-11-19
03665224000693PRODONT-HOLLIGER1290.071290.072021-11-19
03665224000709PRODONT-HOLLIGER1290.081290.082021-11-19
03665224000716PRODONT-HOLLIGER1290.131290.132021-11-19
03665224000723PRODONT-HOLLIGER1290.171290.172021-11-19
03665224000730PRODONT-HOLLIGER1290.181290.182021-11-19
03665224000747PRODONT-HOLLIGER1290.211290.212021-11-19
03665224000754PRODONT-HOLLIGER1290.221290.222021-11-19
03665224000761PRODONT-HOLLIGER1290.331290.332021-11-19
03665224000778PRODONT-HOLLIGER1290.511290.512021-11-19
03665224000785PRODONT-HOLLIGER1290.731290.732021-11-19
03665224000792PRODONT-HOLLIGER1290.751290.752021-11-19
03665224000808PRODONT-HOLLIGER1290.791290.792021-11-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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
00889813065341Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-12-18
00889813065402Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-12-18
00889813065327Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-11-30
00889813065358Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-11-30
00889813065365Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-11-30
00889813065389Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-11-30
00889813065426Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-11-30
00889813065433Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-11-30
00889813065440Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-11-30
00889813065334Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-10-01
00889813065372Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-10-01
00889813065396Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-10-01
00889813065419Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-10-01
00813677024503PDT, Inc.PDT, INC.EKC2024-06-27
00813677024954PDT, Inc.PDT, INC.EKC2024-06-26
00842517109063Karl SchumacherKarl Schumacher Dental, LLCEKC2024-05-06
00842517109070Karl SchumacherKarl Schumacher Dental, LLCEKC2024-05-06