Home GUDID D928105535DLC0 """OH"" ZYGOMA RETRACTOR DLC"
Primary DI D928105535DLC0
Brand """OH"" ZYGOMA RETRACTOR DLC"
Company W.H. Holden, Inc.
Model 10-5535DLC
Published 2026-03-18
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name GAD Retractor
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GAD Retractor General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D928105535DLC0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Dental cheek retractor, professional, reusable A hands-free, self-retaining frame intended to allow a dental professional to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure for easy access to the field of operation. It is designed to be placed in and around the lips/cheeks and may also be designed to displace the tongue. It is a synthetic polymer device which may include suction adaptors/tubing for saliva removal to maintain a dry field. It is not intended to be placed between the teeth (i.e., not a mouth gag). This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 183854322 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D9282000201SUL0 SMITH SAGGITAL SPLITTER-MOD 20-0020-1-SUL 2026-05-27 D928105406HFDLC0 STAHR TUNNEL RETRACTOR HF D/E DLC 10-5406HFDLC 2026-03-18 D9284004001CH0 PERIO FILE SUGARMAN 1S D/E CH HANDLE SPECIAL DR SIN 40-0400-1CH 2026-03-18 D9284004002CH0 PERIO FILE SUGARMAN 2S D/E CH HANDLE SPECIAL DR SIN 40-0400-2CH 2026-03-18 D928400400CH0 PERIO FILE SUGARMAN 1S/2S D/E CH HANDLE 40-0400CH 2026-03-18 D928400400HD0 PERIO FILE SUGARMAN 1S/2S D/E HD HANDLE 40-0400HD 2026-03-18 D928400400HF0 PERIO FILE SUGARMAN 1S/2S D/E HF HANDLE 40-0400HF 2026-03-18 D928400435RD0 PERIO FILE SCHLUGER 9/10 D/E ROUND HANDLE 40-0435RD 2026-03-18 D9281051992HF0 SINUS INSTRUMENT #2 HF D/E 10-5199-2HF 2026-02-19 D928400527H0 POWERTOME S/E HF HANDLE 40-0527H 2026-01-27 D928106122R450 SUCTION TIP #2-REGULAR - 45DEG RIGHT GRIND ANGLE 10-6122-R45 2026-01-15 D9281059552HF570 CURETTE SINUS LARGE PADDLE SHARP, SMALL PADDLE DULL, D/E HANDFORM HANDLE LONG 10-5955-2HF57 2026-01-14 D928400101CH0 PERIO KNIFE GOLDMAN FOX 8 CH HANDLE 40-0101CH 2026-01-14 D928400102CH0 PERIO KNIFE GOLDMAN FOX 11 CH HANDLE 40-0102CH 2026-01-14 D928400102HF0 PERIO KNIFE GOLDMAN FOX 11 HF HANDLE 40-0102HF 2026-01-14 D928400102R0 PERIO KNIFE GOLDMAN FOX 11 ROUND HANDLE 40-0102R 2026-01-14 D9284001040 D9284001040 40-0104 2026-01-14 D928100600962DLC0 EXTRACTION FORCEPS #962 UPPER DLC 10-0600-962DLC 2026-01-06 D9281009301850 RONGEUR DOUBLE ACTION RUSKIN CURVED 18CM, 5MM 10-0930-18-5 2026-01-06 D9281009302390 RONGEUR DOUBLE ACTION RUSKIN CURVED 23CM, 6MM 10-0930-23-6 2026-01-06
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