FDA.reportPublic FDA data

Power Dental USA

Primary DI
D9431105BN00
Brand
Power Dental USA
Company
Power Dental U.S.A. Inc.
Model
1105BN
Catalog number
1105BN
Device description
PROBE CP15UNC (1-2-3-4-5-6-7-8-9-10-11-12-13-14-15) IMPLANT SURGERY BLACK EDITION
Published
2021-07-13
Public version status
Update
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
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL
EIXPROBE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1
EIXProbe, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D9431105BN00PrimaryHIBCC0

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
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
D9431007E0Power Dental USA1007E1007E2021-07-13
D94315240Power Dental USA152415242021-06-20
D94335090Power Dental USA350935092021-06-20
D9434826XAS0Power Dental USA4826XAS4826XAS2021-07-13
D94362100Power Dental USA621062102021-06-20
D94364470Power Dental USA644764472022-01-08
D943813050Power Dental USA8130-58130-52021-07-13
D943DCAM0Power Dental USADCAMDCAM2021-07-13
D943DCAM30Power Dental USADCAM3DCAM32021-07-13
D943KIM10Power Dental USAKIM-1KIM-12022-07-12
D943KIM120Power Dental USAKIM-12KIM-122022-07-12
D943KIM20Power Dental USAKIM-2KIM-22022-07-12
D943KIM240Power Dental USAKIM-24KIM-242021-07-13
D943KIM30Power Dental USAKIM-3KIM-32022-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149NPPEXP0NPSACME ENTERPRISE.EIX2026-05-01
00348783006438Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006629Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006766Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006780Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006803Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006810Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006827Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006841Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00840018674516Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-03-12
00840481135309MICROPRIMEZest Anchors, LLCEID2026-03-10
00840479201115CR MARK II SYRINGERELIANCE ORTHODONTIC PRODUCTS INCEID2026-02-27
B382SD502210Surgical DirectSurgical Direct, Inc.EIX2026-02-26
00840018674097Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-11
00840018667051Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-10
00840018667143Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-10
00840018667792Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-10
00840018666498Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-09
00840018666597Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-09
B382SD12240Surgical DirectSurgical Direct, Inc.EIX2026-02-04
B382SD923898000Surgical DirectSurgical Direct, Inc.EIX2026-02-04
00840018662582Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-01-29
00840018663268Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-01-29
00840018661646Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-01-28
00304040194782Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
00304040194799Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
00304040194805Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
00841013120473Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EIX2026-01-06
D9284002151M0PERIO PROBE MARQUIS STYLE #1 CC 3-6-9-12W.H. Holden, Inc.EIX2026-01-06
00371347019889Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-12-30