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Device Explorer · FDA GUDID · GMDN 65430

Dental delivery system irrigation handpiece tip

A rigid, tubular device intended to be fitted to the distal end of a dental delivery system irrigation handpiece (not included) to direct a stream of pressurized, warmed water and/or air to the field of operation in the oral cavity to irrigate/clear debris dur

US‑registered devices100in commercial distribution
Companies15labelers on GUDID
Single‑use89%of device records
Sterile1%labelled sterile
Prescription23%Rx‑only share
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Share of device records

Young Innovations, Inc.4343%
Dental Health Products Inc2222%
Hager Worldwide, Inc.1111%
Aira, Llc55%
Unipack Medical Corporation33%
Crosstex International, Inc.33%
Dukal Llc33%
Palmero Healthcare Llc22%

Top labelers

CompanyDevicesShare
Young Innovations, Inc.4343%
Dental Health Products Inc2222%
Hager Worldwide, Inc.1111%
Aira, Llc55%
Unipack Medical Corporation33%
Crosstex International, Inc.33%
Dukal Llc33%
Palmero Healthcare Llc22%
Keystone Industries22%
Dental Basics Inc.11%
Cargus International, Inc11%
Jmu Dental, Inc11%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Dental BasicsUnipackStarz TipzCrystal TipAstekDefendMARK3JMUPalmero Healthcare, LLCHealth-Tec/DHP Surgical Aspirating TipsHealth-Tec/DHP High Volume Evacuator TipsHealth-Tec/DHP Air/Water Syringe TipsHealth-Tec/DHP Pre-Bent Dispensing TipsHealth-Tec/DHP Padded Delivery TipsHealth-Tec/DHP Syringes with NeedleHealth-Tec/DHP Irrigating Needle Tips

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

FDA product codes

CodeNameDevices
ECBUNIT, SYRINGE, AIR AND/OR WATER79
EICSyringe, Periodontic, Endodontic, Irrigating15
ECBUnit, Syringe, Air And/Or Water12
EHZEvacuator, oral cavity3
EIBSyringe, irrigating (dental)2
NRDUnit, Operative Dental, Accessories1

GMDN & GCC registration

  • GMDN code 65430 · non‑implantable
  • Single‑use 89% · sterile 1% · Rx‑only 23% · OTC 7%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

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

How many dental delivery system irrigation handpiece tip products are registered in the US?

100 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental delivery system irrigation handpiece tip", from 15 companies. The largest labeler is Young Innovations, Inc. with 43% of records.

Which FDA product codes apply?

ECB (UNIT, SYRINGE, AIR AND/OR WATER), EIC (Syringe, Periodontic, Endodontic, Irrigating), ECB (Unit, Syringe, Air And/Or Water), EHZ (Evacuator, oral cavity)

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?

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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.

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