Device Explorer · FDA GUDID · GMDN 61050

Dental bib

A non-sterile device intended to be worn by a patient during a dental examination or treatment procedure to function as a barrier to soiling and cross-contamination. It typically consists of a shaped piece of natural and/or synthetic material intended to be fa

US‑registered devices348in commercial distribution
Companies27labelers on GUDID
Single‑use91%of device records
Sterile1%labelled sterile
Prescription6%Rx‑only share
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Share of device records

Crosstex International, Inc.7722%
Safco Dental Supply Co.329%
3D Dental Designs And Development, Llc319%
The Atlanta Dental Supply Company319%
Cargus International, Inc288%
Dental Health Products Inc247%
Darby Dental Supply, Llc195%
Jmu Dental, Inc185%

Top labelers

CompanyDevicesShare
Crosstex International, Inc.7722%
Safco Dental Supply Co.329%
3D Dental Designs And Development, Llc319%
The Atlanta Dental Supply Company319%
Cargus International, Inc288%
Dental Health Products Inc247%
Darby Dental Supply, Llc195%
Jmu Dental, Inc185%
Plasdent Corporation123%
Benco Dental Supply Co.103%
Henry Schein, Inc.93%
American Medical & Hospital Supply Co., Inc.82%

Company = labeler of record on GUDID. 27 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CDTopmedHTDarby Dental Supply, LLCBritedentPatient Armor BarriersPlasdentCOMPLETE DENTAL SUPPLIESDefendMARK3JMUAstekScott's Select Patient BibsHealth-Tec Ultra Digital X-Ray Sensor SheathsHealth-Tec Digital X-Ray Sensor SleevesHealth-Tec/DHP Patient Bibs

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

FDA product codes

CodeNameDevices
KHRABSORBER, SALIVA, PAPER201
PEMDental Barriers And Sleeves103
KHRAbsorber, Saliva, Paper68
NRDUnit, Operative Dental, Accessories9
NRUChair, Dental, Without Operative Unit8
PEMDental barriers and sleeves8

GMDN & GCC registration

  • GMDN code 61050 · non‑implantable
  • Single‑use 91% · sterile 1% · Rx‑only 6% · OTC 1%
  • 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) · 3Width (Inch) · 3

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

How many dental bib products are registered in the US?

348 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental bib", from 27 companies. The largest labeler is Crosstex International, Inc. with 22% of records.

Which FDA product codes apply?

KHR (ABSORBER, SALIVA, PAPER), PEM (Dental Barriers And Sleeves), KHR (Absorber, Saliva, Paper), NRD (Unit, Operative Dental, Accessories)

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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