FDA.reportPublic FDA data

PDT, Inc.

Primary DI
00813677024497
Brand
PDT, Inc.
Company
PDT, INC.
Model
R983 Basic Extraction Kit
Catalog number
R983
Device description
Kit Includes:T015E-U FlipTop™ Cassette 'E' – Utility T018FM Silicone Finger Mat 10.75”x 8”R245 Mirror Handle (Cone-Socket)R437 Lucas 86T040 Tweezers COLLEGET050 #5 Front Surface Mirror, Cone-Socket, (15/16')T080 Tissue pliers ADSONT100 Retractor Caewood Minnesota 16T102 Root elevator Seldin No. 301 straightT104 Root elevator Seldin 34ST118 Periosteal Elevator Molt 9 Hollow handleT235 Aspirating Anesthetic Syringe MediumT320 Elevator Fragment Ejector/Root Tip Pick, HEIDBRINKT704 Scalpel handleT714 TC Needle Holder CRILE WOODT813 Scissors Goldman-Fox curved 12.5T850 Miller-Colburn Bone File #1, Serrated
Published
2024-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EAXMirror, Mouth
EGNScissors, Surgical Tissue, Dental
EICSyringe, Periodontic, Endodontic, Irrigating
EIFAccessories, Retractor, Dental
EJBHandle, Instrument, Dental
EJYPliers, Operative
EMIFile, Bone, Surgical
EMJElevator, Surgical, Dental
EMKCurette, Surgical, Dental
FSMTray, Surgical, Instrument
GDZHandle, Scalpel
HXKHolder, Needle; Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAXMirror, MouthDental1
EGNScissors, Surgical Tissue, DentalDental1
EICSyringe, Periodontic, Endodontic, IrrigatingDental1
EIFAccessories, Retractor, DentalDental1
EJBHandle, Instrument, DentalDental1
EJYPliers, OperativeDental1
EMIFile, Bone, SurgicalDental1
EMJElevator, Surgical, DentalDental1
EMKCurette, Surgical, DentalDental1
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
GDZHandle, ScalpelGeneral, Plastic Surgery1
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813677024497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677024497008136770244978136770244970813677024497

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

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

Regulatory Flags#

DUNS number
125850144
Device count
1
Premarket exempt
true
Kit
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

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