FDA.report

The Essentials By 3D Dental

Primary DI
00810126503152
Brand
The Essentials By 3D Dental
Company
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Model
EN12CC
Catalog number
EN12CC
Device description
LUER LOCK DISPOSABLE IRRIGATION 12CC SYRINGES 100/BAG
Published
2023-02-28
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
EIDSyringe, Restorative And Impression Material

Product Code Classifications

CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810126503152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810126503152008101265031528101265031520810126503152

GMDN Terms

TermDefinition
Dental impression material syringe, reusableA non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient's mouth. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080194935
Device count
1
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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