FDA.report

BENCO

Primary DI
00366975004178
Brand
BENCO
Company
BENCO DENTAL SUPPLY CO.
Model
2221-909
Device description
#20 Yellow .02 Taper Benco Dental Gutta Percha Points 28mm Spill Proof Pack of 120
Published
2018-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EKMGutta-Percha

Product Code Classifications

CodeDeviceSpecialtyClass
EKMGutta-PerchaDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00366975004178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00366975004178003669750041783669750041780366975004178

GMDN Terms

TermDefinition
Natural gutta-perchaA dental material made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. This material is softened by heat and inserted into the root canal, where it hardens as it cools. After application, this device cannot be reused.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius27 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
570-602-6924jsoroka@benco.com

Regulatory Flags

DUNS number
015108087
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00366975066961OPTIMUM6032-1972023-02-21
00366975066978OPTIMUM6032-2042023-02-21
00366975066992OPTIMUM6032-2312023-02-21

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