FDA.reportPublic FDA data

Karl Schumacher

Primary DI
00842517119055
Brand
Karl Schumacher
Company
Karl Schumacher Dental, LLC
Model
PFI6352
Device description
Orban Perio File #12-13, Lg I/O
Published
2024-05-06
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMRFILE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMRFile, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842517119055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842517119055008425171190558425171190550842517119055

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal file/rasp, manualA hand-held manual dental instrument that has various forms of ridged cutting surfaces at its working end(s) designed to scrape and smooth during a periodontal procedure. It is typically a one-piece instrument 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 made of metal [e.g., stainless steel, titanium (Ti)]. This device is typically used to remove gross supragingival calculus, smooth the cementoenamel junction (CEJ), and remove overhanging margins of dental restorations. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)523-2427custsvs@karlschumacher.com

Regulatory Flags#

DUNS number
101070070
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
00842517104747Karl SchumacherASP0016T2025-07-08
00842517112360Karl SchumacherNEE00022025-07-08
00842517112384Karl SchumacherNEE00062025-07-08
00842517112421Karl SchumacherNEE00082025-07-08
00842517112438Karl SchumacherNEE0008T2025-07-08
00842517112476Karl SchumacherNEE00112025-07-08
00842517112483Karl SchumacherNEE00122025-07-08
00842517116764Karl SchumacherSCI0667S2025-06-19
00842517104129Karl SchumacherASP0000Y2025-04-23
00842517112568Karl SchumacherNEE06862025-04-23
00842517112582Karl SchumacherNEE06892025-04-23
00842517112599Karl SchumacherNEE06902025-04-23
00842517112629Karl SchumacherNEE06912025-04-23
00842517112780Karl SchumacherNEE07902025-04-23
00842517112803Karl SchumacherNEE07912025-04-23
00842517111417Karl SchumacherHEM06102025-02-05
00842517111424Karl SchumacherHEM06112025-02-05
00842517112209Karl SchumacherMOS06122025-02-05
00842517112216Karl SchumacherMOS06132025-02-05
00842517103603Karl SchumacherAMCBGMS2024-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840018665767Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMR2026-02-09
00840018665774Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMR2026-02-09
00841336110854Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMR2024-12-11
00813677024756PDT, Inc.PDT, INC.EMR2024-05-22
00842517113688Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517118973Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517119048Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517119109Karl SchumacherKarl Schumacher Dental, LLCEMR2024-05-06
00842517106093Karl SchumacherKarl Schumacher Dental, LLCEMR2024-03-15
00842517106109Karl SchumacherKarl Schumacher Dental, LLCEMR2024-03-15
00842517106130Karl SchumacherKarl Schumacher Dental, LLCEMR2024-03-15
00841336101203Salvin Freer Periosteal ElevatorsSalvin Dental Specialties, Inc.EMR2023-08-10
00841336101227Salvin Hirschfeld #20 Periosteal ElevatorSalvin Dental Specialties, Inc.EMR2023-08-10
00841336102286Salvin Goldman-Fox Periosteal Elevator - 17cmSalvin Dental Specialties, Inc.EMR2023-08-10
00841336102385Salvin Molt 9Salvin Dental Specialties, Inc.EMR2023-08-10
00841336102460Salvin West Periosteal ElevatorSalvin Dental Specialties, Inc.EMR2023-08-10
00841336102859Salvin Woodson Elevator - 7" (18cm)Salvin Dental Specialties, Inc.EMR2023-08-10
00841336102866Salvin Bone File #12Salvin Dental Specialties, Inc.EMR2023-08-10
00841336102873Salvin Bone File #10Salvin Dental Specialties, Inc.EMR2023-08-10
00841336102880Salvin Bone File # 12CA Cross CutSalvin Dental Specialties, Inc.EMR2023-08-10
00841336102897Salvin Bone File # 10CA Cross CutSalvin Dental Specialties, Inc.EMR2023-08-10
00841336104150Salvin Molt #2 Single End InstrumentSalvin Dental Specialties, Inc.EMR2023-08-10
00841336104167Salvin Molt 4 Single End InstrumentSalvin Dental Specialties, Inc.EMR2023-08-10
00841336104181Salvin Periosteal-Tome™ Combination Periosteal Elevator & PeriotomeSalvin Dental Specialties, Inc.EMR2023-08-10
00841336104280Salvin Prichard ElevatorSalvin Dental Specialties, Inc.EMR2023-08-10
00841336104327PCHARLES Periosteal ElevatorSalvin Dental Specialties, Inc.EMR2023-08-10
00841336105423Papilla Elevator BlackSalvin Dental Specialties, Inc.EMR2023-08-10
00841336105447Prichard BlackSalvin Dental Specialties, Inc.EMR2023-08-10
10889950012304Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMR2023-06-27
10889950012557Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMR2023-06-27