FDA.report

Core Forms

Primary DI
D701HCF12
Brand
Core Forms
Company
PULPDENT CORPORATION
Model
HCF-1
Device description
Box of 64 – small
Published
2021-09-21
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
true

Related Records

Product Codes

CodeName
EBLPin, Retentive And Splinting, And Accessory Instruments

Product Code Classifications

CodeDeviceSpecialtyClass
EBLPin, Retentive And Splinting, And Accessory InstrumentsDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D701HCF12PrimaryHIBCC0
D701HCF11Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental appliance fabrication material, curedA resin that polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured) intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture base, occlusal splint/night guard); it may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). It consists of a reactive component (e.g., acrylic monomer, reactive polymer) that hardens via polymerization [or vulcanization]. Reinforcing fillers may be included in the resin to increase its strength and/or durability. After application, this material cannot be refabricated.

Sterilization Methods

Method

Regulatory Flags

DUNS number
001006089
Device count
64
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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