FDA.reportPublic FDA data

Opal-Etch

Primary DI
00883205000019
Brand
Opal-Etch
Company
ULTRADENT PRODUCTS, INC.
Model
1863
Catalog number
1863
Device description
Opal Ortho Empty Syringe 1.2ml 20pk
Published
2018-06-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EICSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EICSyringe, Periodontic, Endodontic, IrrigatingDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883205000019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205000019008832050000198832050000190883205000019

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(801)572-4200customerservice@ultradent.com

Regulatory Flags#

DUNS number
013369913
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06944843624365Ultrapro TX Cordless5275-5275-2026-09-19
00883205026286Ultrapro TxS8303S83032026-08-22
00883205029102OpalDam1824-U1824-U2026-08-22
00883205029119OpalDam1825-U1825-U2026-08-22
00883205029126OpalDam1826-U1826-U2026-08-22
00883205029133OpalDam324-U324-U2026-08-22
00883205029140OpalDam325-U325-U2026-08-22
00883205029157OpalDam326-U326-U2026-08-22
00883205041005Thermo Clone606560652026-08-22
00883205041883UltraCem205620562026-08-22
00883205043221ViscoStat Clear640764072026-08-22
00883205043238ViscoStat Clear640864082026-08-22
00883205043245ViscoStat Clear640964092026-08-22
00883205043252ViscoStat Clear641064102026-08-22
00883205043344Valo X5973-DU5973-DU2026-08-22
00883205031976STARbrush109310932024-12-07
00883205040398Halo Sectional Matrix System588358832026-06-26
00883205040978Halo Sectional Matrix System588258822026-06-26
00883205044617Halo Sectional Matrix System993199312026-06-26
00883205044624Halo Sectional Matrix System993299322026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456202418JMUJMU DENTAL, INCEIC2026-07-27
00840456214527JMUJMU DENTAL, INCEIC2026-07-27
00840456214534JMUJMU DENTAL, INCEIC2026-07-27
00840456214541JMUJMU DENTAL, INCEIC2026-07-27
00840456214558JMUJMU DENTAL, INCEIC2026-07-27
00840456214565JMUJMU DENTAL, INCEIC2026-07-27
00840456214572JMUJMU DENTAL, INCEIC2026-07-27
00840456214589JMUJMU DENTAL, INCEIC2026-07-27
00840456214596JMUJMU DENTAL, INCEIC2026-07-27
G149TBSB71040TBS BASICSACME ENTERPRISE.EIC2026-05-22
00371347023466Advance Dental ProductsThe Atlanta Dental Supply CompanyEIC2026-04-14
00371347023473Advance Dental ProductsThe Atlanta Dental Supply CompanyEIC2026-04-14
G1493807003TBS DentalACME ENTERPRISE.EIC2026-03-02
00850014374983MARK3®CARGUS INTERNATIONAL, INCEIC2026-02-05
00850014374990MARK3®CARGUS INTERNATIONAL, INCEIC2026-02-05
00850440008339IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008346IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008353IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008360IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008377IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008384IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008391ES Cap TipsEngineered Endodontics, LLCEIC2026-01-02
00850440008513ES VacEngineered Endodontics, LLCEIC2026-01-02
00850440008520ES VacEngineered Endodontics, LLCEIC2026-01-02
00850440008537ES VacEngineered Endodontics, LLCEIC2026-01-02
00850440008551JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
00850440008568JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
00850440008575JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
008504400086433DPD Paste Delivery TipEngineered Endodontics, LLCEIC2026-01-02
00850440008650Capillary Tip - PremiumEngineered Endodontics, LLCEIC2026-01-02