FDA.report

American Medicals

Primary DI
B356AM43920
Brand
American Medicals
Company
American Medicals
Model
1
Published
2022-12-06
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

Related Records

Product Codes

CodeName
EMJElevator, Surgical, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EMJElevator, Surgical, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B356AM43920PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental elevator, tooth/rootA hand-held, manual, dental surgical instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with a central handle. It is available in a variety of sizes and blade designs and is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments. This is a reusable device.

Sterilization Methods

Method
Microwave Radiation

Regulatory Flags

DUNS number
109909627
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 DIBrandModelCatalogPublished
B356JD259280American Medicals12026-03-09
B356JB543320American Medicals12026-02-26
B356JB641170American Medicals12026-02-06
B356DF370170American Medicals12026-01-30
B356BK905180American Medicals12026-01-27
B356FH454070American Medical12025-12-10
B356FH455060American Medicals12025-12-10
B356ED107160American Medicals12025-12-03
B356JB536280American Medicals12025-11-25
B356KD932040American Medicals12025-09-18
B356KD932070American Medicals12025-09-18
B356KE334280American Medicals12025-09-15
B356KJ522130American Medicals12025-09-12
B356FF131030American Medicals12025-08-16
B356FF131050American Medicals12025-08-16
B356KE292350American Medicals12025-08-15
B356KE295040American Medicals12025-08-15
B356KE296030American Medicals12025-08-15
B356KE312070American Medicals12025-08-15
B356KE328060American Medicals12025-08-15

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00348783004069Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00348783004076Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00348783004182Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00348783004229Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00192896122772Winged ElevatorSONTEC INSTRUMENTS, INC.EMJ2026-03-10
00192896122789Winged ElevatorSONTEC INSTRUMENTS, INC.EMJ2026-03-10
G1493803201TBS DentalACME ENTERPRISE.EMJ2026-03-03
G1493803302TBS DentalACME ENTERPRISE.EMJ2026-03-03
G1493801502TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493801704TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493801805TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493801906TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493802200TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493802301TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493802402TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493802503TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493802604TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493803100TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493803403TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493803504TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493803605TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493807104TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493809106TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493850102TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493850203TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493850304TBS DentalACME ENTERPRISE.EMJ2026-03-02
G149TBSRPKIT00TBS DentalACME ENTERPRISE.EMJ2026-03-02
00840018672369Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMJ2026-02-11
00840018667556Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMJ2026-02-10
00840018666535Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMJ2026-02-09