FDA.reportPublic FDA data

PDT, Inc.

Primary DI
00813677022967
Brand
PDT, Inc.
Company
PDT, INC.
Model
T310 Band Seaters
Catalog number
T310
Device description
T310 Band Seaters
Published
2024-07-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ECRSetter, Band, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECRSetter, Band, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813677022967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677022967008136770229678136770229670813677022967

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic aligner/retainer seater, reusableA small cylindrical pledget intended to be used to facilitate placement and proper seating of an orthodontic progressive aligner or teeth retainer (positioner), by being placed between the partially-aligned aligner/retainer and the opposing set of teeth, allowing the patient to bite down on the device to push the aligner/retainer into place. This is a reusable device intended for single-patient use.

Sterilization Methods#

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

Contacts#

Phone, Email table
PhoneEmail
800-240-9895customer.care@pdtdental.com

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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00850078989321SmileSet Aligner/Retainer Seater/Removal Tool – 4 PackOrtho Dental Lab LLCECR2025-10-01
00889813063699Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCECR2024-11-30
00813677022974PDT, Inc.PDT, INC.ECR2024-07-05
00840326420836Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420843Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420928Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420935Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420942Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
00840326420959Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420833Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420840Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420925Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420932Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420949Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
10840326420956Young SpecialtiesYoung Innovations, Inc.ECR2023-11-16
D1272421031Artman Instruments Wise Linkers, LLCECR2023-03-28
E89656540SCHWERTA. Schweickhardt GmbH & Co. KGECR2023-03-07
E8965654500SCHWERTA. Schweickhardt GmbH & Co. KGECR2023-03-07
E896495010SCHWERTA. Schweickhardt GmbH & Co. KGECR2023-03-06
00817524028805J&J InstrumentsJ & J INSTRUMENTS INCECR2023-03-01
00817524028812J&J InstrumentsJ & J INSTRUMENTS INCECR2023-03-01
00850007728410ALIGNER SEATER PURPLEAccess Dental Lab, LLCECR2023-02-17
EZPF19080120HELMUT ZEPFHelmut Zepf Medizintechnik GmbHECR2022-11-29
EZPF1926200WL0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHECR2022-11-25
00840326408773OrthoquestYoung Innovations, Inc.ECR2022-11-03
00840326408803OrthoquestYoung Innovations, Inc.ECR2022-11-03
10840326408770OrthoquestYoung Innovations, Inc.ECR2022-11-03
10840326408800OrthoquestYoung Innovations, Inc.ECR2022-11-03
04963931227037NAYDM CORPORATIONECR2022-09-30