FDA.reportPublic FDA data

Hemaseal & Cide

Primary DI
10859787002007
Brand
Hemaseal & Cide
Company
ADVANTAGE DENTAL PRODUCTS INC
Model
170
Device description
10mL bottle - dental desensitizer with 4% chlorhexadine
Published
2016-09-16
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LBHVarnish, Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990779000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990779000HEMASEAL & CIDEAdvantage Dental Products, Inc.1999-11-17LBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859787002007PackageGS112In Commercial Distribution
00859787002000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085978700200710859787002007
00859787002000008597870020008597870020000859787002000

GMDN Terms#

Term, Definition table
TermDefinition
Dental coating, tooth-desensitizingA substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
248-391-1625contact@advantagedentalinc.com

Regulatory Flags#

DUNS number
607859147
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
false
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
00859787002062ThermTray1 Quadrant UL-LR 1122016-11-04
00859787002079ThermTray1 Quadrant UR-LL1142016-11-04
00859787002086TherTray1 3/4/-Arch UL-LR1162016-11-04
00859787002093ThermTray1 3/4/-Arch UR-LL1182016-11-04
00859787002109ThermTray1 Anterior1202016-11-04
00859787002017MatrixTemp Temporary Crown and Bridge Material1012016-10-21
00859787002024MatrixTemp Temporary Crown and Bridge Material1022016-10-21
00859787002031MatrixTemp Temporary Crown and Bridge Materail1032016-10-21
00859787002000Hemaseal & Cide 1702016-09-16
00859787002048Hemaseal & Cide - Unidose1802016-09-16
10859787002045Hemaseal & Cide - Unidose1802016-09-16
00859787002055Temporary Crown Matrix Buttons1002016-10-21
10859787002014MatrixTemp Temporary Crown and Bridge Material1012016-10-21
10859787002021MatrixTemp Temporary Crown and Bridge Material1022016-10-21
10859787002038MatrixTemp Temporary Crown and Bridge Materail1032016-10-21
10859787002052Temporary Crown Matrix Buttons1002016-10-21
10859787002069ThermTray1 Quadrant UL-LR 1122016-11-04
10859787002076ThermTray1 Quadrant UR-LL1142016-11-04
10859787002083TherTray1 3/4/-Arch UL-LR1162016-11-04
10859787002090ThermTray1 3/4/-Arch UR-LL1182016-11-04

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00302730003208D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
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