FDA.reportPublic FDA data

ItsoClear

Primary DI
H66810091520
Brand
ItsoClear
Company
Keystone Industries
Model
1009152
Catalog number
1009152
Device description
Clear Universal Clasps (2.2 mm) 36/pkg
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
EHPCLASP, PREFORMED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHPClasp, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H66810091521PrimaryHIBCC0
H66810091520Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Denture clasp, polymer, preformedA prefabricated dental device made of polymer material intended to retain and stabilize a removable partial denture to stationary teeth. It is manufactured to meet a standard specification for adaptation or direct insertion into the patient's mouth.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width2.2Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
073503117
Device count
36
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
J01810171J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810172J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810181J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810182J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810191J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810192J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810211J-Clasp oblique Scheu-Dental GmbHEHP2024-11-19
J01810212J-Clasp obliqueScheu-Dental GmbHEHP2024-11-19
J01810221J-Clasp obliqueScheu-Dental GmbHEHP2024-11-19
J01810222J-Clasp oblique Scheu-Dental GmbHEHP2024-11-19
J01810231JM-ClaspScheu-Dental GmbHEHP2024-11-19
J01810261T-ClaspScheu-Dental GmbHEHP2024-11-19
J01810271T-ClaspScheu-Dental GmbHEHP2024-11-19
J01810471J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810481J-Clasp obliqueScheu-Dental GmbHEHP2024-11-19
J01820481SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820482SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820491SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820492SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820493SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820501SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820502SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820503SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820511SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820512SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820513SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820521SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820522SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820531SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820532SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19