Consulting Wallah › Device Explorer › Dental › Dental restoration carver, resin
Device Explorer · FDA GUDID · GMDN 41861

Dental restoration carver, resin

A hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental composite or acrylic resin restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will

US‑registered devices792in commercial distribution
Companies25labelers on GUDID
Single‑use2%of device records
Sterile3%labelled sterile
Prescription30%Rx‑only share
ShareLinkedIn

Share of device records

Hu-Friedy Mfg. Co., Llc26734%
Nordent Manufacturing Inc9011%
Storz Am Mark Gmbh8110%
Peter Brasseler Holdings, Llc456%
Sklar Corporation385%
A. Titan Instruments, Inc.344%
Lm-Dental324%
Henry Schein, Inc.243%

Top labelers

CompanyDevicesShare
Hu-Friedy Mfg. Co., Llc26734%
Nordent Manufacturing Inc9011%
Storz Am Mark Gmbh8110%
Peter Brasseler Holdings, Llc456%
Sklar Corporation385%
A. Titan Instruments, Inc.344%
Lm-Dental324%
Henry Schein, Inc.243%
Ivoclar Vivadent Aktiengesellschaft223%
Darby Dental Supply, Llc223%
Cosmedent, Inc.223%
Pomee Corporation223%

Company = labeler of record on GUDID. 25 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OptraSculptEna BrushLMDentalDarby Dental Supply, LLCCROWN BUTLERBrasseler USAOptraSculpt Refill SpitzeOptraSculpt Refill ChiselOptraSculpt Refill KugelOptraSculpt Starter KitOptraSculpt and OptraSculpt Pad System KitOptraSculpt Pad RefillOptraSculpt Pad AssortmentPower Dental USAA. Titan InstrumentsCarry & Pack

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
EIYINSTRUMENT, FILLING, PLASTIC, DENTAL453
DZNInstruments, Dental Hand110
EIYInstrument, Filling, Plastic, Dental108
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE46
EKHCARVER, DENTAL AMALGAM, OPERATIVE45
EKFINSTRUMENT, CONTOURING, MATRIX, OPERATIVE41

GMDN & GCC registration

  • GMDN code 41861 · non‑implantable
  • Single‑use 2% · sterile 3% · Rx‑only 30% · OTC 2%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 13Outer Diameter (Millimeter) · 2

Use these as the dimensions to specify in a tender line.

How many dental restoration carver, resin products are registered in the US?

792 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental restoration carver, resin", from 25 companies. The largest labeler is Hu-Friedy Mfg. Co., Llc with 34% of records.

Which FDA product codes apply?

EIY (INSTRUMENT, FILLING, PLASTIC, DENTAL), DZN (Instruments, Dental Hand), EIY (Instrument, Filling, Plastic, Dental), MDM (INSTRUMENT, MANUAL, SURGICAL, GENERAL USE)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

Add dental restoration carver, resin to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

Request quotes for Dental restoration carver, resin

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying dental restoration carver, resin for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

Get quotes →