FDA.report

Hartzell Instruments

Primary DI
D813HZM41
Brand
Hartzell Instruments
Company
DEN-MAT HOLDINGS, LLC
Model
HZM4
Catalog number
HZM4
Device description
#M4 C.S. MIRROR - 1 DOZEN
Published
2018-08-15
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
true

Related Records

Contact Domains

Product Codes

CodeName
EAXMirror, Mouth

Product Code Classifications

CodeDeviceSpecialtyClass
EAXMirror, MouthDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D813HZM41PrimaryHIBCC0
D813HZM40Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental explorerA hand-held manual dental instrument designed for tactile examination (i.e., exploration) in the oral cavity, on the tooth surface and/or gums, mainly to find indentations (e.g., pits, fissures) for the determination of early tooth decay on the crown of teeth; it is also used in periodontology (e.g., to locate subgingival deposits before scaling). It is a long, slender instrument (a manual probe) with a stem that terminates in a thin working part at the distal end which may be needle-like, hooked, or blunt according to the intended use. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-433-6628info@denmat.com

Regulatory Flags

DUNS number
809857704
Device count
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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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