FDA.report

TBS Dental

Primary DI
G1493802402
Brand
TBS Dental
Company
ACME ENTERPRISE.
Model
2.0
Catalog number
38024
Device description
Left Spade Elvatome 2.0
Published
2026-03-02
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
G1493802402PrimaryHIBCC0

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
645459892
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
G1493803201TBS Dental38032380322026-03-03
G1493803302TBS Dental38033380332026-03-03
G14926002A05TBS Dental26002A26002A2026-03-02
G14933001F07TBS Dental33001F33001F2026-03-02
G14933002F08TBS Dental33002F33002F2026-03-02
G14933010F07TBS Dental33010F33010F2026-03-02
G14933011F08TBS Dental33011F33011F2026-03-02
G14933012F09TBS Dental33012F33012F2026-03-02
G14933020F08TBS Dental33020F33020F2026-03-02
G14933021F09TBS Dental33021F33021F2026-03-02
G14934001F08TBS Dental34001F34001F2026-03-02
G1493800400TBS Dental38004380042026-03-02
G1493800501TBS Dental38005380052026-03-02
G1493801502TBS Dental38015380152026-03-02
G1493801704TBS Dental38017380172026-03-02
G1493801805TBS Dental38018380182026-03-02
G1493801906TBS Dental38019380192026-03-02
G1493802200TBS Dental2.0380222026-03-02
G1493802301TBS Dental2.0380232026-03-02
G1493802503TBS Dental2.0380252026-03-02

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
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
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