FDA.reportPublic FDA data

OpalDam

Primary DI
00883205104083
Brand
OpalDam
Company
ULTRADENT PRODUCTS, INC.
Model
1824
Catalog number
1824
Device description
OpalDam Green Kit
Published
2017-12-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIGRETRACTOR, ALL TYPES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIGRetractor, All TypesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883205104083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205104083008832051040838832051040830883205104083

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam, non-latexA sheet of elastomeric synthetic material (e.g., silicone) that is punched with holes and placed over the teeth during dental procedures. It can have a variety of functions such as: 1) to isolate the field of operation from the rest of the oral cavity; 2) to eliminate saliva; 3) to prevent the patient swallowing liquid/dental material; 4) to protect soft tissue from harmful solutions; and 5) to reduce risk of infection. This device may be used for patients and/or staff that have an allergy to latex. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(801)572-4200customerservice@ultradent.com

Regulatory Flags#

DUNS number
013369913
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00883205042835Opalustre5545542026-03-10
00883205044068Enamelast690669062026-02-11
00883205044075Enamelast690769072026-02-11
00883205044082Enamelast691369132026-02-11
00883205044099Enamelast690869082026-02-11
00883205044105Enamelast690969092026-02-11
00883205044112Enamelast691069102026-02-11
00883205044129Enamelast691169112026-02-11
00883205044136Enamelast691269122026-02-11
00883205044983Porcelain Repair110811082026-01-30
00883205044372Valo X6496-DU6496-DU2025-12-04
00883205044389Valo X6497-DU6497-DU2025-12-04
00883205044396Valo X6498-DU6498-DU2025-12-04
00883205044402Valo X6499-DU6499-DU2025-12-04
00883205044419Valo X6519-DU6519-DU2025-12-04
00883205044426Valo X6538-DU6538-DU2025-12-04
00883205044143Enamelast689568952025-11-14
00883205044150Enamelast689668962025-11-14
00883205044167Enamelast689768972025-11-14
00883205044174Enamelast689868982025-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB71000TBS BASICSACME ENTERPRISE.EIG2026-05-22
G149TBSB71020TBS BASICSACME ENTERPRISE.EIG2026-05-22
G149TBSB71030TBS BASICSACME ENTERPRISE.EIG2026-05-22
G149TBSB7990TBS BASICSACME ENTERPRISE.EIG2026-05-22
00190776417567MillenniumAvalign Technologies, Inc.EIG2026-03-04
B382SD1472510000Surgical DirectSurgical Direct, Inc.EIG2026-02-16
B382SD915118280Surgical DirectSurgical Direct, Inc.EIG2026-02-16
B382SD915118290Surgical DirectSurgical Direct, Inc.EIG2026-02-16
B382SD915118300Surgical DirectSurgical Direct, Inc.EIG2026-02-16
04059453109095Hermann Medizintechnik GmbHHermann Medizintechnik GmbHEIG2026-02-13
B382SD5750050Surgical DirectSurgical Direct, Inc.EIG2026-02-10
B382SD9177181010Surgical DirectSurgical Direct, Inc.EIG2026-02-10
B382SD921052010Surgical DirectSurgical Direct, Inc.EIG2026-02-10
00888118150608RETRACTORKLS-Martin L.P.EIG2025-12-23
00810123209712Adler Instrument CompanyAdler, Inc.EIG2025-12-12
B382SD62584SS0Surgical DirectSurgical Direct, Inc.EIG2025-12-08
B382SD62585SS0Surgical DirectSurgical Direct, Inc.EIG2025-12-08
B382SD62586SS0Surgical DirectSurgical Direct, Inc.EIG2025-12-08
00810042124844OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIG2025-11-26
00810042124851OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIG2025-11-26
00810042124868OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIG2025-11-26
B382SD915100320Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100340Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100360Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100430Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100440Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100460Surgical DirectSurgical Direct, Inc.EIG2025-11-11
B382SD915100480Surgical DirectSurgical Direct, Inc.EIG2025-11-11
10190707191150Ortho Technology®Ortho Organizers, Inc.EIG2025-10-23
10190707191167Ortho Technology®Ortho Organizers, Inc.EIG2025-10-23