FDA.reportPublic FDA data

Power Dental USA

Primary DI
D9431980N00
Brand
Power Dental USA
Company
Power Dental U.S.A. Inc.
Model
1980N
Catalog number
1980N
Device description
GRF & PRF CASSETTE
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
FTYTAPE, MEASURING, RULERS AND CALIPERS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D9431980N00PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dressing/utility forceps, scissors-like, reusableA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

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
00888118154255LEVEL ONE EXTREMITYKLS-Martin L.P.FTY2026-05-25
00810180843331Durma+ DynaRule Disposable Paper RulersDynarex CorporationFTY2026-03-24
08806373887703BENCOX Surgical InstrumentsCorentec Co., LtdFTY2026-02-23
00842071152963AMT Balloon Measuring DeviceAPPLIED MEDICAL TECHNOLOGY, INC.FTY2026-02-20
B382SD2644404000Surgical DirectSurgical Direct, Inc.FTY2026-02-16
00757770421848Bausch + LombBausch & Lomb IncorporatedFTY2026-02-11
03662663108072Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2026-02-11
03662663108089Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFTY2026-02-11
B382SD91328410000Surgical DirectSurgical Direct, Inc.FTY2026-02-10
08681506801500SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIFTY2026-02-09
08681506801593ScharfSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIFTY2026-01-31
00847538005479Patella CaliperSYMMETRY MEDICAL INC.FTY2025-12-10
09348811038784INKAThe Trustee for KAISER FAMILY TRUSTFTY2025-12-02
00810207782599Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDFTY2025-11-24
00887868287503Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCFTY2025-11-14
04719846016576CharderCHARDER ELECTRONIC CO., LTD.FTY2025-11-13
00763000684044Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.FTY2025-09-21
B382SD1327110040Surgical DirectSurgical Direct, Inc.FTY2025-09-09
04059453050144Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFTY2025-08-25
00757770405237Bausch + LombBausch & Lomb IncorporatedFTY2025-08-13
00757770413102Bausch + LombBausch & Lomb IncorporatedFTY2025-08-13
00757770450831Bausch + LombBausch & Lomb IncorporatedFTY2025-08-13
00757770676309Bausch + LombBausch & Lomb IncorporatedFTY2025-08-13
00757770413843Bausch + LombBausch & Lomb IncorporatedFTY2025-08-12
00757770422531Bausch + LombBausch & Lomb IncorporatedFTY2025-08-12
00757770669615Bausch + LombBausch & Lomb IncorporatedFTY2025-08-12
20197344154651MEDLINEMEDLINE INDUSTRIES, INC.FTY2025-07-28
00190776406899MillenniumAvalign Technologies, Inc.FTY2025-07-25
04059453186676Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFTY2025-07-23
B382SD1325910000Surgical DirectSurgical Direct, Inc.FTY2025-07-23