FDA.report

ItsoClear

Primary DI
H6681009150M0
Brand
ItsoClear
Company
Keystone Industries
Model
1009150M
Catalog number
1009150M
Device description
Clear Universal Clasps Samples
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

Related Records

Contact Domains

Product Codes

CodeName
EHPCLASP, PREFORMED

Product Code Classifications

CodeDeviceSpecialtyClass
EHPClasp, PreformedDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
H6681009150M1PrimaryHIBCC0
H6681009150M0Unit of UseHIBCC0

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)333-3131tschwear@keystoneind.com

Regulatory Flags

DUNS number
073503117
Device count
3
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

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H66842204411Carbon 422044142304412025-08-28
H66842204421Carbon 422044242304422025-08-28
H66842004331KeyPrint420043342004332025-01-07
H66842004341KeyPrint420043442004342025-01-07
H66842204301KeyPrint422043042204302025-01-07
H66842204311KeyPrint422043142204312025-01-07
H66842204321KeyPrint 422043242204322025-01-07
H66842204331KeyPrint422043342204332025-01-07
H66842204341KeyPrint422043442204342025-01-07
H66842004301KeyPrint420043042004302024-12-17
H66842004311KeyPrint420043142004312024-12-17
H6684200432KeyPrint420043242004322024-12-17
H66842000100KeyPrint420001042000102024-06-25
H6683524850Omni24-4294524-429452024-06-21
H6683524860Omni24-4294624-429462024-06-21
H6683524870Omni24-4294724-429472024-06-21
H6683524880Omni24-4294824-429482024-06-21
H66841101412KeyPrint422014142201412023-09-25
H66842201512KeyPrint422015142201512023-09-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
J01810170J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810180J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810190J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810201J-Clasp obliqueScheu-Dental GmbHEHP2024-11-19
J01810210J-Clasp obliqueScheu-Dental GmbHEHP2024-11-19
J01810220J-Clasp oblique Scheu-Dental GmbHEHP2024-11-19
J01810230JM-ClaspScheu-Dental GmbHEHP2024-11-19
J01810260T-ClaspScheu-Dental GmbHEHP2024-11-19
J01810270T-ClaspScheu-Dental GmbHEHP2024-11-19
J01810470J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810480J-Clasp obliqueScheu-Dental GmbHEHP2024-11-19
J01820480SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820490SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820500SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820510SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820520SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820530SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820550Arrow ClaspScheu-Dental GmbHEHP2024-11-19
J01820560Arrow ClaspScheu-Dental GmbHEHP2024-11-19
J01821040Adams ClaspScheu-Dental GmbHEHP2024-11-19
J01821050Adams ClaspScheu-Dental GmbHEHP2024-11-19
J01821060Adams ClaspScheu-Dental GmbHEHP2024-11-19
J01821070Adams ClaspScheu-Dental GmbHEHP2024-11-19
J01821080Adams ClaspScheu-Dental GmbHEHP2024-11-19
J01821090Adams ClaspScheu-Dental GmbHEHP2024-11-19
00000008857972RMORmo, Inc.EHP2024-08-12
D772198150BALL CLASPS 2000 AMERICAN TOOTH INDUSTRIESEHP2023-08-30
D772ATI0131981560BALL CLASP 2000AMERICAN TOOTH INDUSTRIESEHP2023-08-30
D772ATI198140BALL CLASPS 2000AMERICAN TOOTH INDUSTRIESEHP2023-08-30
H66810091500ItsoClearKeystone IndustriesEHP2022-11-30