FDA.reportPublic FDA data

"""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
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D928105535DLC0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental cheek retractor, professional, reusableA 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 DIBrandModelCatalogPublished
D9282000201SUL0SMITH SAGGITAL SPLITTER-MOD20-0020-1-SUL2026-05-27
D928105406HFDLC0STAHR TUNNEL RETRACTOR HF D/E DLC10-5406HFDLC2026-03-18
D9284004001CH0PERIO FILE SUGARMAN 1S D/E CH HANDLE SPECIAL DR SIN40-0400-1CH2026-03-18
D9284004002CH0PERIO FILE SUGARMAN 2S D/E CH HANDLE SPECIAL DR SIN40-0400-2CH2026-03-18
D928400400CH0PERIO FILE SUGARMAN 1S/2S D/E CH HANDLE40-0400CH2026-03-18
D928400400HD0PERIO FILE SUGARMAN 1S/2S D/E HD HANDLE40-0400HD2026-03-18
D928400400HF0PERIO FILE SUGARMAN 1S/2S D/E HF HANDLE40-0400HF2026-03-18
D928400435RD0PERIO FILE SCHLUGER 9/10 D/E ROUND HANDLE40-0435RD2026-03-18
D9281051992HF0SINUS INSTRUMENT #2 HF D/E10-5199-2HF2026-02-19
D928400527H0POWERTOME S/E HF HANDLE40-0527H2026-01-27
D928106122R450SUCTION TIP #2-REGULAR - 45DEG RIGHT GRIND ANGLE10-6122-R452026-01-15
D9281059552HF570CURETTE SINUS LARGE PADDLE SHARP, SMALL PADDLE DULL, D/E HANDFORM HANDLE LONG10-5955-2HF572026-01-14
D928400101CH0PERIO KNIFE GOLDMAN FOX 8 CH HANDLE40-0101CH2026-01-14
D928400102CH0PERIO KNIFE GOLDMAN FOX 11 CH HANDLE40-0102CH2026-01-14
D928400102HF0PERIO KNIFE GOLDMAN FOX 11 HF HANDLE40-0102HF2026-01-14
D928400102R0PERIO KNIFE GOLDMAN FOX 11 ROUND HANDLE40-0102R2026-01-14
D9284001040D928400104040-01042026-01-14
D928100600962DLC0EXTRACTION FORCEPS #962 UPPER DLC10-0600-962DLC2026-01-06
D9281009301850RONGEUR DOUBLE ACTION RUSKIN CURVED 18CM, 5MM10-0930-18-52026-01-06
D9281009302390RONGEUR DOUBLE ACTION RUSKIN CURVED 23CM, 6MM10-0930-23-62026-01-06

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B382SD914172160Surgical DirectSurgical Direct, Inc.GAD2026-07-24
B382SD9141731000Surgical DirectSurgical Direct, Inc.GAD2026-07-24
B382SD9141781300Surgical DirectSurgical Direct, Inc.GAD2026-07-24
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