FDA.reportPublic FDA data

Belixa

Primary DI
00766054003151
Brand
Belixa
Company
ESSENTIAL DENTAL SYSTEMS, INC.
Model
1417-20
Catalog number
1417-20
Device description
Mixing Tips
Published
2026-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIYINSTRUMENT, FILLING, PLASTIC, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIYInstrument, Filling, Plastic, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00766054003151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00766054003151007660540031517660540031510766054003151

Contacts#

Phone, Email table
PhoneEmail
+1(201)487-9090udi@edsdental.com

Regulatory Flags#

DUNS number
101147171
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00766054003045Belixa1400-A11400-A12026-11-01
00766054003052Belixa1400-A21400-A22026-11-01
00766054003069Belixa1400-A31400-A32026-11-01
00766054003076Belixa1400-BW1400-BW2026-11-01
00766054003083Belixa1401-A11401-A12026-11-01
00766054003090Belixa1401-A21401-A22026-11-01
00766054003106Belixa1401-A31401-A32026-11-01
00766054003113Belixa1401-BW1401-BW2026-11-01
00766054003120Belixa1450-A21450-A22026-11-01
00766054003137Belixa1451-A21451-A22026-11-01
00766054003144Belixa1413-201413-202026-11-01
00766054002956CEMPOWER940-00940-002026-09-21
00766054002963BIOSEAL1640-001640-002026-09-21
00766054002987Turbo-CR1100-301100-302025-04-04
00766054002994Turbo-CR1100-001100-002025-04-04
00766054003007Turbo-CR1100-1001100-1002025-04-04
00766054002949BIOSEAL1640-001640-002024-10-31
00766054002970BIOSEAL1640-151640-152024-10-31
00766054000341EDS Self Etch Bonding Agent900-00900-002017-02-01
00766054000693Tango-Endo5300-005300-002020-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00766054003144BelixaESSENTIAL DENTAL SYSTEMS, INC.EIY2026-11-01
06954454000809COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-30
06954454002711COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-30
06954454005163COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-30
06954454006528COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-30
06954454001615COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454002681COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454002698COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004227COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004234COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004241COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004258COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004265COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004272COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004289COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004296COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004302COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004319COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454006382COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454006399COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454006405COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454012024COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454014523COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454014530COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454014547COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015230COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015360COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015377COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015384COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015391COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27