FDA.report

Hysolate

Primary DI
07630392900577
Brand
Hysolate
Company
Dent4You AG
Model
H05688
Device description
HySolate Dental Dam Clamp winged #2A Premolar, 1 clamp
Published
2023-02-28
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
false

Related Records

Product Codes

CodeName
EEFClamp, Rubber Dam

Product Code Classifications

CodeDeviceSpecialtyClass
EEFClamp, Rubber DamDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07630392900577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07630392900577076303929005777630392900577

GMDN Terms

TermDefinition
Rubber dam clampA dental device with a buccal and lingual wing, or flange, used to anchor a rubber dam down to the cervical region of an exposed tooth. This device comes in a variety of shapes, sizes, and designs for various situations. It is typically made of spring metal and has bevelled jaws that contact the tooth, and a bow that connects the jaws. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
480152811
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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