FDA.reportPublic FDA data

Keystone Industries

Primary DI
H66819007600
Brand
Keystone Industries
Company
Keystone Industries
Model
1900760
Catalog number
1900760
Device description
Pkg/10x1 Ft Clasp Wire 17Ga Rd
Published
2022-11-30
Public version status
New
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
EJWCLASP, WIRE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJWClasp, WireDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H66819007601PrimaryHIBCC0
H66819007600Unit 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
Width1.4Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
073503117
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
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
H66819007401Keystone 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
H66819007700Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007800Keystone IndustriesKeystone IndustriesEJW2022-11-30
H66819007900Keystone IndustriesKeystone IndustriesEJW2022-11-30