FDA.reportPublic FDA data

Anti-snoring, denture

Primary DI
06972677871266
Brand
Anti-snoring, denture
Company
Modern Dental Laboratory (DG) Co., Ltd.
Model
126
Published
2020-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LRKDevice, Anti-Snoring
NSLDentures, Full

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRKDevice, Anti-SnoringDental2
NSLDentures, FullUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972677871266PrimaryGS10
06972677871273Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972677871266069726778712666972677871266
06972677871273069726778712736972677871273

GMDN Terms#

Term, Definition table
TermDefinition
Complete upper dentureA custom-made artificial replacement for all teeth in the upper jaw (maxilla) carried on a removable plate or frame which is supported by surrounding soft and hard tissues of the oral cavity. It can be made of a variety of materials including polymers [polymethylmethacrylate (PMMA), polycarbonate (PC)], acrylic, ceramics, and/or metals [e.g., base metal alloys or titanium (Ti)].

Regulatory Flags#

DUNS number
551746187
Device count
2
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972677871648Senture, surgical guide1642020-07-21
06972677879989Denture,restoration,orthodontic,anti-snoring,orthodontic9982020-07-30
06972677870108Surgical Guide0102020-07-21
06972677870245ZenSplint0242026-04-28
06972677870214Trioclear System S,H2023-09-04
06972677870221Trioclear SystemS2023-09-04
06972677870238Trioclear SystemH2023-09-04
06972677871129Denture, splint1122020-07-21
06972677871143Anti-snoring, splint1142020-07-21
06972677871167Anti-snoring, splint1162020-07-21
06972677871242Restoration, splint1242020-07-21
06972677871341Restoration, splint1342020-07-21
06972677871402Restoration, splint1402020-07-21
06972677871525Denture, splint1522020-07-21
06972677871587Restoration, splint1582020-07-21
06972677871761Pink EF Series,Retainer1762022-08-26
06972677871785Blue Series,Splint1782022-08-26
06972677871808Pink Series,Splint1802022-08-26
06972677871846Pink EF Series,Splint1842022-08-26
06972677873147Restoration, orthodontic3142020-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850077473005EMA NOW PATIENT STARTER KITSEMA SLEEP INCORPORATEDLRK2026-08-14
00850077473012EMA Serena Patient Starter kitsEMA SLEEP INCORPORATEDLRK2026-08-14
00850077473043INDIVIDUAL EMA STRAPS(EMAST13W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473050Individual EMA Straps(EMAST14W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473067Individual EMA Straps(EMAST15W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473074Individual EMA Straps(EMAST16W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473081Individual EMA Straps(EMAST17W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473098Individual EMA Straps(EMAST18W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473104Individual EMA Straps(EMAST19W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473111Individual EMA Straps(EMAST20W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473128Individual EMA Straps(EMAST21W)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473135Individual EMA Straps(EMAST13Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473142Individual EMA Straps(EMAST14Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473159Individual EMA Straps(EMAST15Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473166Individual EMA Straps(EMAST16Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473173Individual EMA Straps(EMAST17Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473180Individual EMA Straps(EMAST18Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473197Individual EMA Straps(EMAST19Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473203Individual EMA Straps(EMAST20Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473210Individual EMA Straps(EMAST21Y)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473227Individual EMA Straps(EMAST13B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473234Individual EMA Straps(EMAST14B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473241Individual EMA Straps(EMAST15B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473258Individual EMA Straps(EMAST16B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473265Individual EMA Straps(EMAST17B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473272Individual EMA Straps(EMAST18B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473289Individual EMA Straps(EMAST19B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473296Individual EMA Straps(EMAST20B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473302Individual EMA Straps(EMAST21B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473319Individual EMA Straps(EMAST13C)EMA SLEEP INCORPORATEDLRK2026-08-14