FDA.reportPublic FDA data

Power Dental USA

Primary DI
D9436427T00
Brand
Power Dental USA
Company
Power Dental U.S.A. Inc.
Model
6427T
Catalog number
6427T
Device description
MOUTH GAG CHILD SIZE, BLUE REPLACEMENT TIPS
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
KBNGAG, MOUTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBNGag, MouthEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D9436427T00PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Mouth gag, adjustable, reusableA mechanical device with adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral/dental surgical intervention. Also known as a jaw spreader, it is available in various designs having support structures that force and/or hold the jaws apart; e.g., it may be designed with flat, pivoted blades that angle outward when adjusted; or it may have two parallel plates that move apart with adjustments to a centre screw; or it may have a scissors-like design with pivoted, self-retaining, notched blades at the distal end. 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
G149TBSB71210TBS BASICSACME ENTERPRISE.KBN2026-05-22
G149TBSB71220TBS BASICSACME ENTERPRISE.KBN2026-05-22
G14926002A05TBS DentalACME ENTERPRISE.KBN2026-03-02
G1493807205TBS DentalACME ENTERPRISE.KBN2026-03-02
04250676735287McIvor mouth gagSpiggle & Theis Medizintechnik GmbHKBN2025-09-19
04250676735300Dehnhardt mouth gagSpiggle & Theis Medizintechnik GmbHKBN2025-09-19
00194613045401MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613049294MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
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00194613088033MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
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00194613098087MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
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00757770412792Bausch + LombBausch & Lomb IncorporatedKBN2025-07-29
00757770431748Bausch + LombBausch & Lomb IncorporatedKBN2025-07-29
D92810605610MOUTH PROP LARGE ADULT-GRAY W/ HARGIS/MARTIN ATTACHMENTW.H. Holden, Inc.KBN2025-07-22
D92810605810MOUTH PROP ENDENTULOUS, GRAY W/ HARGIS/MARTIN ATTACHMENTW.H. Holden, Inc.KBN2025-07-22
00810123209330Adler Instrument CompanyAdler, Inc.KBN2025-05-23
00810123209347Adler Instrument CompanyAdler, Inc.KBN2025-05-23