FDA.reportPublic FDA data

PDT, Inc.

Primary DI
00813677024862
Brand
PDT, Inc.
Company
PDT, INC.
Model
R917 PDT Amazing Gracey™ Prophy Kit
Catalog number
R917
Device description
Kit Includes: T009C-F C-Series FlipTop™ Cassette - Fixed Rack 9 R026 Amazing Gracey™ 11-12 R028 Amazing Gracey™ 13-14 R061 Barnhart 5-6 R130 Jack B. Nimble® R138 Montana Jack® R144 Queen of Hearts™ R167 11-12 ODU Explorer R195 Probe 12 (3-6-9-12) R245 Cone Socket Mirror Handle T050 #5 Mirror (15/16")
Published
2024-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EMNScaler, Periodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMNScaler, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813677024862PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677024862008136770248628136770248620813677024862

GMDN Terms#

Term, Definition table
TermDefinition
Dental mirror, reusableA hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
125850144
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00813677025319PDT, Inc.T804 Beebee Crown Curved Scissors (10.5cm)T8052025-09-03
00813677025258PDT, Inc.AU026 Gracey 11/12AU0262025-08-14
00813677025265PDT, Inc.AU028 Gracey 13-14AU0282025-08-14
00813677025272PDT, Inc.AU061 Barnhart 5-6AU0612025-08-14
00813677025289PDT, Inc.AU110 H6-7AU1102025-08-14
00813677025296PDT, Inc.AU135 204SAU1352025-08-14
00813677025302PDT, Inc.AU138 Ouback JackAU1382025-08-14
00813677023018PDT, Inc.T315 Millimeter RulerT3152025-05-12
00813677025241PDT, Inc.R218 Montana Precision ProbeR2182025-05-07
00813677025234PDT, Inc.R245-M Mirror Handle (Cone-Socket)-Missions R245-M2025-04-23
00813677025210PDT, Inc.R908 - PDT Demo Wallet 3 Pack - HygieneR9082025-03-25
00813677025227PDT, Inc.R909 - PDT Wallet 3 Pack - DoctorR9092025-03-25
00813677025197PDT, Inc.R138-25 25th Anniversary Montana Jack®R138-252025-02-20
00813677025180PDT, Inc.R960 2024 Advent CalendarR9602024-11-27
00813677025173PDT, Inc.R960 2024 Advent CalendarR9602024-11-06
00813677024138PDT, Inc.T018FM Silicone Finger MatT018FM2024-10-16
00813677025159PDT, Inc.R338 21B-27 BurnisherR3382024-09-11
00813677025166PDT, Inc.R528 CSS-7 Composite SystemR5282024-09-11
00813677025142PDT, Inc.R985 Rev B Andy RDH Student KitsR983 Rev C2024-08-29
00813677025135PDT, Inc.R983 Rev C Basic Extraction KitR983 Rev C2024-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783006858Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
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00348783007343Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007350Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
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00348783007381Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007404Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007411Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007428Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007442Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007459Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
G149TBS204S01TBS DentalACME ENTERPRISE.EMN2026-03-02
G149TBSAS1208TBS DentalACME ENTERPRISE.EMN2026-03-02
G149TBSG171800TBS DentalACME ENTERPRISE.EMN2026-03-02
G149TBSLADY02TBS DentalACME ENTERPRISE.EMN2026-03-02
10889950145590Hu_FriedyHU-FRIEDY MFG. CO., LLCEMN2026-01-30
10889950145569Hu_FriedyHU-FRIEDY MFG. CO., LLCEMN2026-01-22