FDA.reportPublic FDA data

PDT, Inc.

Primary DI
00813677025227
Brand
PDT, Inc.
Company
PDT, INC.
Model
R909 - PDT Wallet 3 Pack - Doctor
Catalog number
R909
Device description
Kit Contains:R227 Explorer 23/Probe UNC-12R518 CSS-3 Gold Line™ Composite Sculpting SystemR362 113 Off Angle Cord Packer
Published
2025-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DZNInstruments, Dental Hand
EIXProbe, Periodontic
EIYInstrument, Filling, Plastic, Dental
EKBExplorer, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1
EIXProbe, PeriodonticDental1
EIYInstrument, Filling, Plastic, DentalDental1
EKBExplorer, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813677025227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677025227008136770252278136770252270813677025227

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical probe, reusableA slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Dry Heat Sterilization""]"
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Regulatory Flags#

DUNS number
125850144
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813677025395PDT, Inc.R117 Boge Precision DuoR1172026-05-12
00813677025388PDT, Inc.R098MB R098MB2026-04-27
00813677023230PDT, Inc.T732 Stieglitz 30° Splinter ForcepT7322024-07-02
00813677025364PDT, Inc.T055-3 Double-Sided PrecisionReflect HD Mirror ThrT055-32025-10-20
00813677025371PDT, Inc.T055-6 Double-Sided PrecisionReflect HD Mirror TweT055-62025-10-20
00813677025326PDT, Inc."T050-3 #5 PrecisionReflect HD Mirror (15/16"") ThT050-32025-10-16
00813677025333PDT, Inc."T050-12 #5 PrecisionReflect HD Mirror (15/16"") TT050-122025-10-16
00813677025340PDT, Inc."T051-3 #4 PrecisionReflect HD Mirror (7/8"") ThreT051-32025-10-16
00813677025357PDT, Inc."T051-12 #4 PrecisionReflect HD Mirror (7/8"") ThrT051-122025-10-16
00813677025319PDT, Inc.T805 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
00813677022455PDT, Inc.T044 Titanium TweezersT0442024-07-05
00813677023612PDT, Inc.T845 Bone Carrier (3.5mm)T8452024-07-02
00813677023629PDT, Inc.T846 Bone Carrier (4.5mm)T8462024-07-02
00813677023636PDT, Inc.T847 Bone Carrier (6mm)T8472024-07-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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ETDG1620542NAmedmix Deutschland GmbHDZN2024-09-15
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07649988072451OdneFill TipOdne AGEIY2024-02-01
07615208296303OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTDZN2023-08-07
ETDG1620662NAmedmix Deutschland GmbHDZN2023-01-26
ETDG1620672NAmedmix Deutschland GmbHDZN2023-01-26
ETDG1620682NAmedmix Deutschland GmbHDZN2023-01-26
ETDG1620692NAmedmix Deutschland GmbHDZN2023-01-26
07615208437980Cavifil InjectorIVOCLAR VIVADENT AKTIENGESELLSCHAFTDZN2022-11-17
ESAM7242201STOMA®Storz am Mark GmbHDZN2022-11-07
00842092112588Stick®Preat CorporationDZN2022-10-24
ESAM12011101STOMA®Storz am Mark GmbHEIY2020-08-27
ESAM12011111STOMA®Storz am Mark GmbHEIY2020-08-27
ESAM12012101STOMA®Storz am Mark GmbHEIY2020-08-27
ESAM12013101STOMA®Storz am Mark GmbHEIY2020-08-27