FDA.report

TBS Dental

Primary DI
G14926002A05
Brand
TBS Dental
Company
ACME ENTERPRISE.
Model
26002A
Catalog number
26002A
Device description
Cheek/Tissue/Lip Retractor
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
KBNGag, Mouth

Product Code Classifications

CodeDeviceSpecialtyClass
KBNGag, MouthEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G14926002A05PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental cheek retractor, professional, reusableA hands-free, self-retaining frame intended to allow a dental professional to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure for easy access to the field of operation. It is designed to be placed in and around the lips/cheeks and may also be designed to displace the tongue. It is a synthetic polymer device which may include suction adaptors/tubing for saliva removal to maintain a dry field. It is not intended to be placed between the teeth (i.e., not a mouth gag). 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
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
G1493802402TBS Dental2.0380242026-03-02
G1493802503TBS Dental2.0380252026-03-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
G1493807205TBS DentalACME ENTERPRISE.KBN2026-03-02
04250676735287McIvor mouth gagSpiggle & Theis Medizintechnik GmbHKBN2025-09-19
04250676735300Dehnhardt mouth gagSpiggle & Theis Medizintechnik GmbHKBN2025-09-19
00194613045401MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613049294MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613049300MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613049317MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613062125MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613088033MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613097981MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613098087MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613098094MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613098117MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613098124MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613114107MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613115432MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613119072MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613119089MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613120269MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613120474MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613120863MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00757770412792Bausch + LombBausch & Lomb IncorporatedKBN2025-07-29
00757770431748Bausch + LombBausch & Lomb IncorporatedKBN2025-07-29
D92810605610MOUTH PROP LARGE ADULT-GRAY W/ HARGIS/MARTIN ATTACHMENTW.H. Holden, Inc.KBN2025-07-22
D92810605810MOUTH PROP ENDENTULOUS, GRAY W/ HARGIS/MARTIN ATTACHMENTW.H. Holden, Inc.KBN2025-07-22
00810123209330Adler Instrument CompanyAdler, Inc.KBN2025-05-23
00810123209347Adler Instrument CompanyAdler, Inc.KBN2025-05-23
00190776398774MillenniumAvalign Technologies, Inc.KBN2025-05-21
04049047373537GimmiGimmi GmbHKBN2025-05-21
04049047373551GimmiGimmi GmbHKBN2025-05-21