FDA.reportPublic FDA data

INTRAORAL REPAIR KIT

Primary DI
D757B22300K1
Brand
INTRAORAL REPAIR KIT
Company
BISCO INC.
Model
B-22300K
Catalog number
B-22300K
Published
2017-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBCSEALANT, PIT AND FISSURE, AND CONDITIONER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D757B22300K1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resin kitA collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes composite resin material and additional materials to support restoration (e.g., etching solution, bonding agent, primer, prosthesis bonding agents, unfilled resin sealant/coating agents), and may include dedicated disposable devices associated with application; it does not include non-resin-based cements nor dental prosthesis. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(847)534-6000sales@bisco.com

Regulatory Flags#

DUNS number
053529939
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810111543323QuantiumH-100A2SH-100A2S2025-07-29
00810111543330QuantiumH-110A2SH-110A2S2025-07-29
00810111543347QuantiumH-110A2PSH-110A2PS2025-07-29
10810111541500Aelite Aesthetic EnamelH-852B4H-852B42023-01-16
10810111541548Aelite Aesthetic EnamelH-852FRH-852FR2023-01-16
10810111542255eCementC-5201C-52012023-01-17
20810111541606Aelite Aesthetic EnamelH-854A4H-854A42023-01-16
20810111541637Aelite Aesthetic EnamelH-854B3H-854B32023-01-16
20810111541644Aelite Aesthetic EnamelH-854B4H-854B42023-01-16
20810111541651Aelite Aesthetic EnamelH-854D2H-854D22023-01-16
20810111541668Aelite Aesthetic EnamelH-854D4H-854D42023-01-16
20810111541682Aelite Aesthetic EnamelH-854FRH-854FR2023-01-16
10810111542996QuantiumH-100A1H-100A12025-07-14
10810111543009QuantiumH-100A2H-100A22025-07-14
10810111543016QuantiumH-100A3H-100A32025-07-14
10810111543023QuantiumH-100A35H-100A352025-07-14
10810111543030QuantiumH-100B1H-100B12025-07-14
10810111543047QuantiumH-100B2H-100B22025-07-14
10810111543054QuantiumH-130BLCH-130BLC2025-07-14
10810111543061QuantiumH-110A1H-110A12025-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115053340Quick SealB.J.M. LABORATORIES LTDEBC2026-03-13
00810118106460NuSmile NuNamel Pit & Fissure SealantNUSMILE, LTD.EBC2025-07-24
00810118106477NuSmile NuNamel Pit & Fissure SealantNUSMILE, LTD.EBC2025-07-24
00810118106484NuSmile NuNamel Pit & Fissure SealantNUSMILE, LTD.EBC2025-07-24
09336472011352CONSEALSDI LIMITEDEBC2025-01-08
09336472011376CONSEALSDI LIMITEDEBC2025-01-08
09336472011413CONSEALSDI LIMITEDEBC2025-01-08
09336472011420CONSEALSDI LIMITEDEBC2025-01-08
09336472016326RIVA COATSDI LIMITEDEBC2025-01-08
09336472016760RIVA CONDITIONERSDI LIMITEDEBC2025-01-08
09336472017248RIVA PROTECTSDI LIMITEDEBC2025-01-08
09336472017309RIVA PROTECTSDI LIMITEDEBC2025-01-08
09336472017316RIVA PROTECTSDI LIMITEDEBC2025-01-08
09336472017347RIVA PROTECTSDI LIMITEDEBC2025-01-08
09336472017378RIVA PROTECTSDI LIMITEDEBC2025-01-08
J014661002680VENUS Diamond FLOWKulzer GmbHEBC2024-10-24
J014661002690VENUS Diamond FLOWKulzer GmbHEBC2024-10-24
J014661002700VENUS Diamond FLOWKulzer GmbHEBC2024-10-24
J014661002710VENUS Diamond FLOWKulzer GmbHEBC2024-10-24
J014661002720VENUS Diamond FLOWKulzer GmbHEBC2024-10-24
J014661002730VENUS Diamond FLOWKulzer GmbHEBC2024-10-24
J014661002740VENUS Diamond FLOWKulzer GmbHEBC2024-10-24
J014661002750VENUS Diamond FLOWKulzer GmbHEBC2024-10-24
J014661003060VENUS Diamond FLOWKulzer GmbHEBC2024-10-24
D77819950610Scott's Select ColorFil Flow Single-Shade PrismaticSCOTT'S DENTAL SUPPLY L.L.C.EBC2024-08-27
D77819950630Scott's Select ColorFil Flow BlockerSCOTT'S DENTAL SUPPLY L.L.C.EBC2024-08-27
07615208445565Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2024-04-04
07615208453492Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2024-04-04
07615208472653Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2024-04-04
07615208445572Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2024-04-04