FDA.reportPublic FDA data

Keystone Industries

Primary DI
H66819007401
Brand
Keystone Industries
Company
Keystone Industries
Model
1900740
Catalog number
1900740
Device description
Pkg/5x1 Ft Clasp Wire 15Ga H/R
Published
2022-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJWCLASP, WIRE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJWClasp, WireDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H66819007401PrimaryHIBCC0
H66819007400Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Denture clasp, metal, custom-madeA dental device made of metal, typically in wire form, intended to retain and stabilize a removable partial denture to stationary teeth. It is manufactured to meet the specifications of an individual patient.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width1.5Millimeter

Contacts#

Phone, Email table
PhoneEmail
+1(800)333-3131tschwear@keystoneind.com

Regulatory Flags#

DUNS number
073503117
Device count
5
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H66842201141HeyGears422011442201142023-02-20
H66842201151KeySplint Soft for HeyGears422011542201152021-07-06
H66850524011Nexa3D425020542502052023-02-20
H66852233011Nexa3D425020442502042023-02-20
H6682030051iSmile070137707013772023-02-20
H66807003771Seity070037707003772016-09-15
H66807021771M&S070217707021772017-10-11
H66807027771Seity070277707027772016-10-26
H66842204400Carbon 422044042304402025-08-28
H66842204410Carbon 422044142304412025-08-28
H66842204420Carbon 422044242304422025-08-28
H66842204401Carbon 422044042304402025-08-28
H66842204411Carbon 422044142304412025-08-28
H66842204421Carbon 422044242304422025-08-28
H668166361BOSWORTH16636166362022-11-30
H668166961BOSWORTH16696166962022-11-30
H66811475771Keystone Industries114757711475772022-11-30
H66811475781Keystone Industries114757811475782022-11-30
H668166301BOSWORTH16630166302022-11-30
H668166321BOSWORTH16632166322022-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840124521056PolyLock MidfootFUSION ORTHOPEDICS, LLCEJW2025-06-24
H66819007201Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007301Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007501Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007601Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007701Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007801Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007901Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007200Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007300Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007400Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007500Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007600Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007700Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007800Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007900Keystone IndustriesKeystone IndustriesEJW2022-11-30