FDA.report

BENCO

Primary DI
00366975005182
Brand
BENCO
Company
BENCO DENTAL SUPPLY CO.
Model
5095-443
Device description
Roach Wax Carver
Published
2018-11-01
Public version status
Update
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

Contact Domains

Product Codes

CodeName
GDZHandle, Scalpel

Product Code Classifications

CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00366975005182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00366975005182003669750051823669750051820366975005182

GMDN Terms

TermDefinition
Dental plastic restoration carverA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental plastic restorations, e.g., for cutting, scraping, paring, and smoothing finishes and fashioning patterns (non-patient-contact). It will typically be a double-ended metal instrument with a solid blunt blade/nib of various sizes and designs with a central handle. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
570-602-6924jsoroka@benco.com

Regulatory Flags

DUNS number
015108087
Device count
1
DM exempt
true
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
false

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00366975066893OPTIMUM6032-1152023-02-21
00366975066909OPTIMUM6032-1242023-02-21
00366975066916OPTIMUM6032-1332023-02-21
00366975066923OPTIMUM6032-1422023-02-21
00366975066930OPTIMUM6032-1512023-02-21
00366975066947OPTIMUM6032-1602023-02-21
00366975066954OPTIMUM6032-1792023-02-21
00366975066961OPTIMUM6032-1972023-02-21
00366975066978OPTIMUM6032-2042023-02-21
00366975066992OPTIMUM6032-2312023-02-21

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