FDA.report

TBS Dental

Primary DI
G14934001F08
Brand
TBS Dental
Company
ACME ENTERPRISE.
Model
34001F
Catalog number
34001F
Device description
Crown Removing FRINGS® w/ 20 Extra Pads
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
EISRemover, Crown

Product Code Classifications

CodeDeviceSpecialtyClass
EISRemover, CrownDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G14934001F08PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental prosthesis removal instrumentA non-electric, hand-held dental instrument intended to be used to remove a permanent or temporary cemented dental prosthesis restoration (e.g., crown, denture, bridge) from a tooth or implant abutment; it is not a thermal detacher. It consists of a metallic instrument with a handle and a pointed, angled distal end used to secure the instrument at the margin of the prosthesis to be removed; it may be designed as a manual, pneumatic or spring-loaded instrument whereby light force is applied to detach the restoration; some types are referred to as crown spreaders. 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
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
G1493802402TBS Dental2.0380242026-03-02
G1493802503TBS Dental2.0380252026-03-02

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