FDA.reportPublic FDA data

Power Dental U.S.A., Inc.

Primary DI
D943N1102E00
Brand
Power Dental U.S.A., Inc.
Company
Power Dental U.S.A. Inc.
Model
N1102E
Catalog number
N1102E
Device description
PROBE CP10 (1-2-3-5-7-8-9-10) 6EZ
Published
2021-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIXPROBE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIXProbe, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D943N1102E00PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal probe, reusableA hand-held dental instrument intended to be inserted into a periodontal pocket around a tooth to measure the depth of the periodontal pocket, in order to assess the health of the periodontium and to monitor the progress of disease. It is typically made of high-grade stainless steel and has a distal end with a thin, angled or curved blunt tip with scaled markings to indicate measurements (typically millimetres). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(815)363-8003info@mydentalusa.com

Regulatory Flags#

DUNS number
081305064
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D94320240Power Dental USA202420242021-06-20
D94341260Power Dental USA412641262021-06-20
D943ORCAA0Power Dental USAORCAAORCAA2021-06-20
D94367350Power Dental USA673567352021-06-20
D94367380Power Dental USA673867382021-06-20
D94367390Power Dental USA673967392021-06-20
D94367410Power Dental USA674167412021-06-20
D94367430Power Dental USA674367432021-06-20
D94367140Power Dental USA671467142021-06-20
D94367420Power Dental USA674267422021-06-20
D9436710E0Power Dental USA6710E6710E2021-07-13
D94367310Power Dental USA673167312021-06-20
D94367320Power Dental USA673267322021-06-20
D94367150Power Dental USA671567152021-06-20
D9436716Power Dental USA671667162021-06-20
D9436733Power Dental USA673367332021-06-20
D9436734Power Dental USA673467342021-06-20
D9436740Power Dental USA674067402021-06-20
D9436750Power Dental USA675067502022-01-08
D9431007E0Power Dental USA1007E1007E2021-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10856364008100Florida ProbeFlorida Probe CorporationEIX2023-08-08
07898506811861QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811878QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811885QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811892QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811908QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811915QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811922QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506839414QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506843862QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506849239QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506849253QuinelatoSchobell Industrial LtdaEIX2022-12-08
07899798200258QuinelatoSchobell Industrial LtdaEIX2022-12-08
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