FDA.report

PRODONT-HOLLIGER

Primary DI
03665224017448
Brand
PRODONT-HOLLIGER
Company
PRODONT-HOLLIGER
Model
246.05SI
Catalog number
246.05SI
Device description
cement spatula sple n° 5 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

Related Records

Product Codes

CodeName
DZNInstruments, Dental Hand

Product Code Classifications

CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03665224017448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03665224017448036652240174483665224017448

GMDN Terms

TermDefinition
Dental restoration carver, amalgam, reusableA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a reusable device.

Sterilization Methods

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

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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

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06438311708720LMDentalLM-DentalDZN2026-03-23
06438311708737LMDentalLM-DentalDZN2026-03-23
06438311708744LMDentalLM-DentalDZN2026-03-23
06438311708751LMDentalLM-DentalDZN2026-03-23
06438311708768LMDentalLM-DentalDZN2026-03-23
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