FDA.reportPublic FDA data

Enigma Denture Teeth - Pairs

Primary DI
05052674041242
Brand
Enigma Denture Teeth - Pairs
Company
DAVIS SCHOTTLANDER & DAVIS LIMITED
Model
ET:D3:D66K
Published
2024-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELMDenture, plastic, teeth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05052674041242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05052674041242050526740412425052674041242

GMDN Terms#

Term, Definition table
TermDefinition
Resin artificial teethPrefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight0.003Kilogram

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441462480848sales@schottlander.co.uk

Regulatory Flags#

DUNS number
210080271
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05052674000003enigmalife Anterior Denture Teeth A1:IR1ELA:A1:IR102024-07-01
05052674000010enigmalife Anterior Denture Teeth A1:IR4ELA:A1:IR42024-07-01
05052674000027enigmalife Anterior Denture Teeth A1:IR6ELA:A1:IR62024-07-01
05052674000034enigmalife Anterior Denture Teeth A1:IR8ELA:A1:IR82024-07-01
05052674000041enigmalife Anterior Denture Teeth A1:IS4ELA:A1:IS42024-07-01
05052674000058enigmalife Anterior Denture Teeth A1:IS6ELA:A1:IS62024-07-01
05052674000065enigmalife Anterior Denture Teeth A1:IS8ELA:A1:IS82024-07-01
05052674000072enigmalife Anterior Denture Teeth A1:IT4ELA:A1:IT42024-07-01
05052674000089enigmalife Anterior Denture Teeth A1:IT6ELA:A1:IT62024-07-01
05052674000096enigmalife Anterior Denture Teeth A1:IT8ELA:A1:IT82024-07-01
05052674000102enigmalife Anterior Denture Teeth A1:L10ELA:A1:L102024-07-01
05052674000119enigmalife Anterior Denture Teeth A2:IR1ELA:A2:IR102024-07-01
05052674000126enigmalife Anterior Denture Teeth A2:IR4ELA:A2:IR42024-07-01
05052674000133enigmalife Anterior Denture Teeth A2:IR6ELA:A2:IR62024-07-01
05052674000140enigmalife Anterior Denture Teeth A2:IR8ELA:A2:IR82024-07-01
05052674000157enigmalife Anterior Denture Teeth A2:IS4ELA:A2:IS42024-07-01
05052674000164enigmalife Anterior Denture Teeth A2:IS6ELA:A2:IS62024-07-01
05052674000171enigmalife Anterior Denture Teeth A2:IS8ELA:A2:IS82024-07-01
05052674000188enigmalife Anterior Denture Teeth A2:IT4ELA:A2:IT42024-07-01
05052674000195enigmalife Anterior Denture Teeth A2:IT6ELA:A2:IT62024-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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