FDA.report

COMPOSITE FILLING INSTRUMENTS

Primary DI
00840479201054
Brand
COMPOSITE FILLING INSTRUMENTS
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
CFI-01
Published
2026-02-27
Public version status
New
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
00840479201054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840479201054008404792010548404792010540840479201054

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
113170088
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

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00840479201481RENEW SYSTEM POINTSFGSAM22026-03-13
00840479203614ULTRA VIOLET MINI LIGHTUVML2026-03-13
00840479203621RETAINIUM LINGUAL RETENTION WIREXLRETSAM2026-03-13
00840479203652EXCEL REGULARERJAF2026-03-13
00840479203669SYRINGE WING (1)WING2026-03-13
00840479203249RETAINIUM LINGUAL RETENTION WIRERET2026-03-12
00840479203256RETAINIUM LINGUAL RETENTION WIREXLRET2026-03-12
00840479203263RETAINIUM LINGUAL RETENTION WIRERETSAM2026-03-12
00840479203270MIXING RESERVOIR RING WELRW2026-03-12
00840479203287MIXING RESERVOIR RING WELRWSAM2026-03-12
00840479203294RELIAMOLDSRMK2026-03-12
00840479203300RELIAMOLDSRMKB2026-03-12
00840479203317RELY A BONDRPF2026-03-12
00840479203324RELIAWAXRWX2026-03-12
00840479203331RELIAWAXRWXSAM2026-03-12
00840479203348SPATULAS2026-03-12
00840479203355SAFETY GLASSESSG2026-03-12
00840479203362SAFETY GLASSESSGU2026-03-12
00840479203379BOND A BRAID 6 INCH LINGUAL RETAINER WIRESSAMBAB22026-03-12
00840479203409SELF ETCHING PRIMER REFILL CARTRIDGESEPR2026-03-12

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
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
00840018665705Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCDZN2026-02-09