FDA.report

CAD/CAM Full Denture PEEK

Primary DI
06975031821136
Brand
CAD/CAM Full Denture PEEK
Company
Beijing Yingguan Dental Technology Co., Ltd.
Model
/
Published
2022-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
ELMDenture, Plastic, Teeth

Product Code Classifications

CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06975031821136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06975031821136069750318211366975031821136

GMDN Terms

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)].

Sterilization Methods

Method
Ozone;Ultraviolet Light

Regulatory Flags

DUNS number
560456141
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
06975031820016Cast Crown Ni-Cr (NP)/2022-09-30
06975031820023Cast Crown Co Cr (NP)/2022-09-30
06975031820030Cast Crown Pure Tianium/2022-09-30
06975031820047Cast Crown Noble Metal/2022-09-30
06975031820054PFM Crown Ni-Cr (NP)/2022-09-30
06975031820061PFM Crown Co Cr (NP)/2022-09-30
06975031820078PFM Crown Pure Titanium/2022-09-30
06975031820085PFM Crown Noble Metal/2022-09-30
06975031820092Cast Pontic Ni-Cr/2022-09-30
06975031820108Cast Pontic Co Cr/2022-09-30
06975031820115Cast Pontic Pure Titanium/2022-09-30
06975031820122Cast Pontic Noble Metal/2022-09-30
06975031820139PFM Pontic Ni-Cr/2022-09-30
06975031820146PFM Pontic Co Cr/2022-09-30
06975031820153PFM Pontic Pure Titanium/2022-09-30
06975031820160PFM Pontic Noble Metal/2022-09-30
06975031820177Fused Resin Pontic Ni-Cr/2022-09-30
06975031820184Fused Resin Pontic Co Cr/2022-09-30
06975031820191Fused Resin Pontic Pure Titanium/2022-09-30
06975031820207Fused Resin Pontic Noble Metal/2022-09-30

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00817169029304Joy by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELM2026-03-11
05056079069658Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070036Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070043Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070050Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070067Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070074Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070081Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070098Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070449Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070456Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070463Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070470Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070487Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070494Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070500Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070517Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070524Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070531Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070548Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070555Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070562Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070579Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070586Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070593Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070609Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070616Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070623Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070630Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070647Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18