FDA.reportPublic FDA data

PDT, Inc.

Primary DI
00813677021489
Brand
PDT, Inc.
Company
PDT, INC.
Model
R270 4/5 DC
Catalog number
R270
Published
2021-04-30
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
EKHCarver, Dental Amalgam, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKHCarver, Dental Amalgam, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813677021489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813677021489008136770214898136770214890813677021489

GMDN Terms#

Term, Definition table
TermDefinition
Dental restoration carver, amalgam, reusableA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
125850144
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
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
00348783009156Premier CarversPREMIER DENTAL PRODUCTS COMPANYEKH2026-03-17
00348783009231Premier CarversPREMIER DENTAL PRODUCTS COMPANYEKH2026-03-17
00840018674035Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKH2026-02-11
00840018674134Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKH2026-02-11
00840018674141Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKH2026-02-11
00840018674158Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKH2026-02-11
05010058180185InstrapacROBINSON HEALTHCARE LIMITEDEKH2025-06-23
00889813066058Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066065Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066089Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066096Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066102Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066119Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066126Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066133Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066140Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00841013116803American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKH2024-11-06
00813677025111PDT, Inc.PDT, INC.EKH2024-07-05
00813677021465PDT, Inc.PDT, INC.EKH2024-06-27
00842517106970Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517106987Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517106994Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517107007Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517107014Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517107021Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517107038Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517118225Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517118683Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517118690Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517118706Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06