FDA.reportPublic FDA data

Crystal HD® Mouth Mirrors

Primary DI
00840161312174
Brand
Crystal HD® Mouth Mirrors
Company
ZIRC DENTAL PRODUCTS, INC.
Model
50Z365N
Device description
Crystal HD - Resin Mouth Mirror - #5 Soft Grip - Neon Blue - 1 Count
Published
2026-10-12
Public version status
New
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
EAXMirror, Mouth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAXMirror, MouthDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840161312174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840161312174008401613121748401613121740840161312174

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0

Contacts#

Phone, Email table
PhoneEmail
7636826636orders@zirc.com

Regulatory Flags#

DUNS number
064783913
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
00840161312181Crystal HD® Mouth Mirrors50Z385S2026-10-12
00840161312198Crystal HD® Mouth Mirrors50Z383-NEON2026-10-12
00840161311894Airway Armor® - Throat Guard - Large - 1 Count5Z960LG2026-05-01
00840161311900Airway Armor® - Throat Guard - Medium - 1 Count5Z960MD2026-05-01
00840161311917Airway Armor® - Throat Guard - Small - 1 Count5Z960SM2026-05-01
00840161307118Mr. Thirsty® One-Step - High Volume Evacuator - Large - 1 Count5Z989LG2026-04-30
00840161307132Mr. Thirsty® One-Step - High Volume Evacuator - Medium5Z989MD2026-04-30
00840161311887Mr. Thirsty® One-Step - High Volume Evacuator - Small5Z989SM2026-04-30
00840161311948Crystal HD® Mouth Mirrors50Z384SMPL2026-04-27
00840161311955Crystal HD® - Resin Mouth Mirror - #5 Soft Grip - 1 Count Sample Pack50Z364SMPL2026-04-27
10840161304794Airway Armor®50Z960SM2022-10-07
10840161304800Airway Armor®50Z960MD2022-10-07
10840161304817Airway Armor®50Z960LG2022-10-07
00840161304797Airway Armor® - Throat Guard - Small - 25 Count50Z960SM2026-04-07
00840161304803Airway Armor® - Throat Guard - Medium - 25 Count50Z960MD2026-04-07
00840161304810Airway Armor® - Throat Guard - Large - 25 Count50Z960LG2026-04-07
60840161307110Mr. Thirsty® One-Step - Large (with 10mm and 16mm Adaptors) - 50 Count50Z989LG10/162026-04-08
60840161307134Mr. Thirsty® One-Step - Medium (with 10mm and 16mm Adaptors) - 50 Count50Z989MD10/162026-04-08
60840161307158Mr. Thirsty® One-Step - Small (with 10mm and 16mm Adaptors) - 50 Count50Z989SM10/162026-04-08
70840161307117Mr. Thirsty® One-Step - Large (with 10mm and 16mm Adaptors) - 100 Count50Z989LG-B10/162026-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454010143COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-04
06954454010150COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-04
06954454010167COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-04
06954454010174COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-04
06954454010181COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-04
06954454010198COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-04
06954454013243COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-04
06954454013250COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-04
06954454013267COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-04
06954454013274COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-04
06954454000755COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454000762COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454006931COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454010129COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454010136COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454010204COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454012291COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454012840COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454012987COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454013168COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454013175COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454013182COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454013199COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454013205COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454013212COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454013229COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
06954454013236COTISENHuanghua Promisee Dental Co., Ltd.EAX2026-11-03
00850090726102Intrace USAPILOTIS TECH LLCEAX2026-10-31
00850090726119Intrace USAPILOTIS TECH LLCEAX2026-10-31
00840456225424JMUJMU DENTAL, INCEAX2026-10-14