FDA.reportPublic FDA data

Power Dental USA

Primary DI
D9436950S00
Brand
Power Dental USA
Company
Power Dental U.S.A. Inc.
Model
6950S
Catalog number
6950S
Device description
MIRROR X POWER SET. ALL FRONT SURFACE MIRROR. SET OF 7
Published
2022-01-08
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
DZNINSTRUMENTS, DENTAL HAND
FTXMIRROR, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1
FTXMirror, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D9436950S00PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental ultrasonic surgical system handpiece tipA removable endpiece intended to be attached to a dental ultrasonic surgical system handpiece, and makes contact with a patient while oscillating (vibrating) at high frequency in order to mechanically fragment and cut bone during dental surgery. The device is available in a variety of forms (e.g., flat serrated blade, ball head, nail head, or probe-like) and sizes, and is typically made of metal; it is not intended to be held directly (i.e., does not include a holder). It is used for implant site preparation, dental extraction, distraction, sinus lift, periodontal surgery, cyst removal, extraction of bone block, bone harvesting, osteoplasty, and osteotomy. 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
true
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
D9431225M0Power Dental USA1225M1225M2021-07-13
D94312400Power Dental USA124012402021-06-20
D9431610R0Power Dental USA1610R1610R2021-07-13
D9431610T0Power Dental USA1610T1610T2021-07-13
D9431611R0Power Dental USA1611R1611R2021-07-13
D9431612R0Power Dental USA1612R1612R2021-07-13
D9431613R0Power Dental USA1613R1613R2021-07-13
D94316140Power Dental USA161416142021-06-20
D9431614T0Power Dental USA1614T1614T2021-07-13
D94316150Power Dental USA161516152021-06-20
D9431615R0Power Dental USA1615R1615R2021-07-13
D9431615T0Power Dental USA1615T1615T2021-07-13
D94316160Power Dental USA161616162021-06-20
D9431617R0Power Dental USA1617R1617R2021-07-13
D9434101SB0Power Dental USA4101SB4101SB2021-06-20
D9434102SB0Power Dental USA4102SB4102SB2021-06-20
D9434126B0Power Dental USA4126B4126B2021-06-20
D94312390Power Dental USA123912392021-06-20
D9431614R0Power Dental USA1614R1614R2021-07-13
D94315240Power Dental USA152415242021-06-20

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Primary DI, Brand, Company table
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D955BBGA551Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA701Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BONDNG1Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
00810226102231AiraAIRA, LLCDZN2026-08-26
00810226102248AiraAIRA, LLCDZN2026-08-26
00198506092688ELMED INCORPORATEDELMED INCORPORATEDDZN2026-07-28
E0HM39MI2071Bone ManagementHager & Meisinger Gesellschaft mit beschränkter HaftungDZN2026-07-24
E0HM39MI2081Bone ManagementHager & Meisinger Gesellschaft mit beschränkter HaftungDZN2026-07-24
00190776403867MillenniumAvalign Technologies, Inc.DZN2026-07-21
10860013564701CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564718CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564725CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564732CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564756CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564763CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564770CurvaGc Orthodontics America Inc.DZN2026-05-28
07898488905190INSTRUMENT FOR ICERAM SLB BRACKETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
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G149TBSB7500TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7510TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7520TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7530TBS BASICSACME ENTERPRISE.DZN2026-05-21
08404535018929Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535018950Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019049Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019070Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019131Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29