FDA.reportPublic FDA data

BONDPRO™ GLASS IONOMER CEMENT POWDER/LIQUID KIT

Primary DI
10190886000649
Brand
BONDPRO™ GLASS IONOMER CEMENT POWDER/LIQUID KIT
Company
G & H Wire Company, Inc.
Model
M965K-01
Device description
An advanced formula designed as a multipurpose final cement for the cementation of orthodontic bands. The cement is radio-opaque and has cariostatic properties by naturally releasing fluoride.Kit contents: 18gm powder, 17.5ml liquid, 50 sheet mixing pads, measuring scoop, instructions.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYHAdhesive, Bracket And Tooth Conditioner, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981036000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981036000SMARTBONDGac Intl., Inc.1999-04-05DYH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190886000649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019088600064910190886000649

GMDN Terms#

Term, Definition table
TermDefinition
Glass ionomer dental cementA non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit75 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1 317-346-6655orders@ghortho.com

Regulatory Flags#

DUNS number
831465641
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190886271612G&H ORTHODONTICS ®131-L5-8RK-V2026-02-27
10190886271629G&H ORTHODONTICS ®131-L5-8LK-V2026-02-27
10190886271841G&H ORTHODONTICS ®131-L5-2RK-V2026-02-27
10190886271858G&H ORTHODONTICS ®131-L5-2LK-V2026-02-27
10190886271025G&H ORTHODONTICS ®130-U1-8R-V2026-02-27
10190886271032G&H ORTHODONTICS ®130-U1-8L-V2026-02-27
10190886271049G&H ORTHODONTICS ®130-U2-8R-V2026-02-27
10190886271056G&H ORTHODONTICS ®130-U2-8L-V2026-02-27
10190886271063G&H ORTHODONTICS ®130-U3-8RK-V2026-02-27
10190886271070G&H ORTHODONTICS ®130-U3-8LK-V2026-02-27
10190886271087G&H ORTHODONTICS ®130-U4-8RK-V2026-02-27
10190886271094G&H ORTHODONTICS ®130-U4-8LK-V2026-02-27
10190886271100G&H ORTHODONTICS ®130-U4-8U-V2026-02-27
10190886271117G&H ORTHODONTICS ®130-L1-8U-V2026-02-27
10190886271124G&H ORTHODONTICS ®130-L3-8RK-V2026-02-27
10190886271131G&H ORTHODONTICS ®130-L3-8LK-V2026-02-27
10190886271148G&H ORTHODONTICS ®130-L4-8U-V2026-02-27
10190886271155G&H ORTHODONTICS ®130-L4-8RK-V2026-02-27
10190886271162G&H ORTHODONTICS ®130-L4-8LK-V2026-02-27
10190886271179G&H ORTHODONTICS ®130-L5-8U-V2026-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998073557SolventumSolventum Orthodontics CorporationDYH2026-10-25
00197998073564SolventumSolventum Orthodontics CorporationDYH2026-10-25
00197998073571SolventumSolventum Orthodontics CorporationDYH2026-10-25
00197998062407SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998062551SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998062988SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998062995SolventumSolventum Orthodontics CorporationDYH2026-10-24
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00197998063015SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063169SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063176SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063183SolventumSolventum Orthodontics CorporationDYH2026-10-24
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00197998063213SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063244SolventumSolventum Orthodontics CorporationDYH2026-10-24
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00197998063268SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063275SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063299SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063305SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063312SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063329SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063947SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063954SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063961SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063978SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063985SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063992SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998064005SolventumSolventum Orthodontics CorporationDYH2026-10-24