FDA.reportPublic FDA data

Hysolate

Primary DI
07630392901017
Brand
Hysolate
Company
Dent4You AG
Model
H02801
Device description
HySolate Fiesta Dental Dam Clamp wingless W2, W2A, W3, W7, W8, W8A, W9, W14A, W56 , 9 clamps
Published
2023-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EEFClamp, Rubber Dam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EEFClamp, Rubber DamDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630392901017PrimaryGS10
17630392901014Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630392901017076303929010177630392901017
1763039290101417630392901014

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480152811
Device count
9
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630243660995Alpen Diamonds60032007600320072026-09-04
07630243661237Alpen Diamonds60032031600320312026-09-04
07630243662470Alpen Diamonds60032155600321552026-09-04
07630243662494Alpen Diamonds60032157600321572026-09-04
07630243662517Alpen Diamonds60032159600321592026-09-04
07630243662531Alpen Diamonds60032161600321612026-09-04
07630243662555Alpen Diamonds60032163600321632026-09-04
07630243662579Alpen Diamonds60032165600321652026-09-04
07630243662593Alpen Diamonds60032167600321672026-09-04
07630243662616Alpen Diamonds60032169600321692026-09-04
07630243662630Alpen Diamonds60032171600321712026-09-04
07630243662654Alpen Diamonds60032173600321732026-09-04
07630243662678Alpen Diamonds60032175600321752026-09-04
07630243662692Alpen Diamonds60032177600321772026-09-04
07630243662715Alpen Diamonds60032179600321792026-09-04
07630243662739Alpen Diamonds60032181600321812026-09-04
07630243662753Alpen Diamonds60032183600321832026-09-04
07630243662777Alpen Diamonds60032185600321852026-09-04
07630243662791Alpen Diamonds60032187600321872026-09-04
07630243662814Alpen Diamonds60032189600321892026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G879RDC000DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC12A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC12AB0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC13A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC13AB0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC14A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC20DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2000DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2010DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC201B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2020DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC202B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2030DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2040DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2050DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2060DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC206B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2070DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC207B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2080DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2090DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC210B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC211B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC2120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC240DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC24B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22
G879RDC250DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEEF2026-08-22