FDA.report

Compo-Dots Composite Condensing Dots Firm

Primary DI
00723896010716
Brand
Compo-Dots Composite Condensing Dots Firm
Company
PRACTICON, INC.
Model
13113
Catalog number
71-05712
Device description
Firm Compo-Dots help condense higher viscosity composites more easily. Ideal for use with Class I, II and III preps.
Published
2018-07-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DZNInstruments, Dental Hand

Product Code Classifications

CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00723896010716PrimaryGS10
00723896003114Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00723896010716007238960107167238960107160723896010716
00723896003114007238960031147238960031140723896003114

GMDN Terms

TermDefinition
Dental material application tool, single-useA hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
119193803
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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 DIBrandModelCatalogPublished
00723896029855Practicon Color Splash™ Saliva Ejectors 100/Pack715824771582472026-01-08
00723896029886Practicon Bliss™ Level 3 Face Mask 50/Box Black7158246 BLA7158246 BLA2026-01-08
00723896029916Practicon Bliss™ Level 3 Face Mask 50/Box Blue7158246 BLU7158246 BLU2026-01-08
00723896030295ECOsply™ Biodegradable Disposable Impression Trays Large Upper 10/Pack715824971582492026-01-08
00723896030325ECOsply™ Biodegradable Disposable Impression Trays Large Lower 10/Pack715825071582502026-01-08
00723896030356ECOsply™ Biodegradable Disposable Impression Trays Medium Upper 10/Pack715825171582512026-01-08
00723896030387ECOsply™ Biodegradable Disposable Impression Trays Medium Lower 10/Pack715825271582522026-01-08
00723896030417ECOsply™ Biodegradable Disposable Impression Trays Small Upper 10/Pack715825371582532026-01-08
00723896030448ECOsply™ Biodegradable Disposable Impression Trays Small Lower 10/Pack715825471582542026-01-08
00723896030479ECOsply™ Biodegradable Disposable Impression Trays Quadrant UR/LL 10/Pack715825571582552026-01-08
00723896030509ECOsply™ Biodegradable Disposable Impression Trays Quadrant UL/LR 10/Pack715825671582562026-01-08
00723896030530ECOsply™ Biodegradable Disposable Impression Trays Anterior Upper 10/Pack715825771582572026-01-08
00723896030561ECOsply™ Biodegradable Disposable Impression Trays Anterior Lower 10/Pack715825871582582026-01-08
00723896030592ECOsply™ Biodegradable Disposable Impression Trays Assortment 10/Pack715825971582592026-01-08
00723896025321TTL Easy Size 2.5X Loupes Red7131117 RED7131117 RED2026-01-07
00723896025338TTL Easy Size 3.0X Loupes Red7131118 RED7131118 RED2026-01-07
00723896025505TTL Easy Size 2.5X Loupes Silver7131117 SIL7131117 SIL2026-01-07
00723896025512TTL Easy Size 3.0X Loupes Silver7131118 SIL7131118 SIL2026-01-07
00723896029558Practicon® Standard 2x2 Non-Woven Sponges 200/Pack715823871582382026-01-07
00723896029589Practicon® Premium 2x2 Non-Woven Sponges 200/Pack715824071582402026-01-07

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06438311708676LMDentalLM-DentalDZN2026-03-23
06438311708683LMDentalLM-DentalDZN2026-03-23
06438311708690LMDentalLM-DentalDZN2026-03-23
06438311708706LMDentalLM-DentalDZN2026-03-23
06438311708713LMDentalLM-DentalDZN2026-03-23
06438311708720LMDentalLM-DentalDZN2026-03-23
06438311708737LMDentalLM-DentalDZN2026-03-23
06438311708744LMDentalLM-DentalDZN2026-03-23
06438311708751LMDentalLM-DentalDZN2026-03-23
06438311708768LMDentalLM-DentalDZN2026-03-23
00348783008807Premier Cord PackersPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783008890Premier Cord PackersPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009552Premier SpatulaPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009569Premier SpatulaPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009859Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009897Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009903Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00840479202594RELIABOX PRE-PASTED STORAGE BOXRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
00840479202600RELIABOX PRE-PASTED STORAGE BOXRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
00840479203119RELIABOX ANTERIOR BRACKET HOLDING TWEEZERSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
00840479203126RELIABOX POSTERIOR BRACKET HOLDING TWEEZERSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
10840481136013BULK EZZest Anchors, LLCDZN2026-03-10
00840479201054COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
00840479201061COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
00840479201078COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
00840479201085COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
00840479201092COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
00840479201108COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
00840479200750RELIAPRY ALIGNER REMOVAL TOOLRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-23
00840018667129Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCDZN2026-02-10