FDA.reportPublic FDA data

Power Dental USA

Primary DI
D9431611R0
Brand
Power Dental USA
Company
Power Dental U.S.A. Inc.
Model
1611R
Catalog number
1611R
Device description
Gracey Curette AF3/4 – Rigid
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
DZNINSTRUMENTS, DENTAL HAND
EMKCURETTE, SURGICAL, DENTAL
EMNSCALER, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1
EMKCurette, Surgical, DentalDental1
EMNScaler, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D9431611R0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal curetteA hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(815)363-8003info@powerdentalgroup.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
false
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
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
D94316170Power Dental USA161716172021-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226102231AiraAIRA, LLCDZN2026-08-26
00810226102248AiraAIRA, LLCDZN2026-08-26
G879102177H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102184H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G8791021850DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102185H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102186H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102187H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102191H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102196H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102197H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102211H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102212H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102213H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G8791024050DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102RM340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G8791021780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102178H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G8791028180DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102818S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102818STIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102818TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G8791028190DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102819S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102819STIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102819TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G8791028200DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102820S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102820STIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102820TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15