Who can help prepare an FDA 510(k) submission like SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS

Q: Who is the manufacturer of SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS?

S.S. White Mfg., Ltd. filed the 510(k) submission for SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS (K964179).

Q: What is the FDA product code for SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS?

EBF. It is classified under 21 CFR 872.3690 as a Class 2 device in the Dental panel.

Q: What is the regulatory pathway for SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS?

Zenith 40% Phosphoric Acid Gel (K890464).

K964179 · S.S. White Mfg., Ltd. · EBF · Jan 9, 1997 · Dental

Device Facts

Record ID	K964179
Device Name	SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS
Applicant	S.S. White Mfg., Ltd.
Product Code	EBF · Dental
Decision Date	Jan 9, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3690
Device Class	Class 2

Intended Use

These materials are intended for use in preparation of tooth material prior to restoration by etching of the surface.

Device Story

Super-Dent Etching Gel and Micro-Etch Gel are phosphoric acid-based gels used in dental clinics. Applied by dentists to tooth surfaces via syringe and hollow applicator to etch enamel/dentin prior to restoration. Gel formulation provides visibility and viscosity to prevent migration to sensitive oral tissues. Increased viscosity improves adhesion compared to predicate. Washed away with water after etching process. Enhances bonding surface for restorative materials.

Clinical Evidence

No clinical data.

Technological Characteristics

Aqueous gel containing nominal 40% ortho-phosphoric acid. Colored for visibility. High viscosity for localized placement. Delivered via syringe and hollow applicator. Manual application.

Indications for Use

Indicated for dental patients requiring surface etching of tooth material prior to restorative procedures.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

Zenith 40% Phosphoric Acid Gel (K890464)

Related Devices

K990306 — HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025 · Kay See Dental Mfg. Co. · Mar 3, 1999
K112597 — SEITY 37% PHOSPHORIC ACID ETCHANT GEL · Mycone Dental Supply Co., Inc. · Dec 7, 2011
K200462 — EtchPro Etching Gel · Belport Company, Inc., Gingi-Pak · Sep 2, 2020
K031915 — PULPDENT ETCH-RITE ROYALE · Pulpdent Corporation · Aug 5, 2003
K152110 — e-1 etchants · E Dental Products · Nov 20, 2015

Submission Summary (Full Text)

{0} SWHITE SS White Manufacturing 9 Madleaze Estate, Bristol Road, Gloucester, GL1 5SG. England. Telephone: (01452) 307171. Fax: (01452) 307187 K964179 JAN. 9, 1997 # PREMARKET NOTIFICATION 510(k) SUMMARY NAME: S.S. White Manufacturing ADDRESS: Unit 9, Madleaze Estate, Bristol Road, Gloucester, GL1 5SG England PHONE No: 01452 307171 FAX No.: 01452 307187 CONTACT: Hugh Savell SS White Group Compliance Manager DATE PREPARED: 9th October, 1996 # {1} PAGE 19 OF 33 # PREMARKET NOTIFICATION 510(k) SUMMARY (continued) ## TRADE NAMES: - Super-Dent Etching Gel - Super-Dent Micro-Etch Gel - Super-Dent Etching Gel Syringe Tips ## COMMON NAME: Phosphoric acid etching gel ## CLASSIFICATION NAME: Dental cement accessory, phosphoric acid etching gel ## EQUIVALENT TO: Zenith 40% Phosphoric Acid Gel 510(k) No. K890464 ## DESCRIPTION: These materials consist of a gel containing ortho-phosphoric acid. ## INTENDED USE: These materials are intended for use in preparation of tooth material prior to restoration by etching of the surface. ## TECHNOLOGICAL CHARACTERISTICS: Both devices are aqueous gels containing a nominal 40% ortho-phosphoric acid and delivered directly to the restoration site from a syringe via a hollow applicator. Both devices are coloured for visibility in contrast with tooth material. They are sufficiently viscous to remain where placed and avoid potentially harmful contamination of more sensitive oral tissues. Both devices wash readily from the site when etching is complete. The subject device is intentionally more viscous than the predicate device to improve adhesion after placement. {2} PAGE 20 OF 33 # PREMARKET NOTIFICATION 510(k) SUMMARY (continued) ## NON-CLINICAL DATA: Non-clinical testing includes tests for pH, acid content, adhesion and water washability. The tests indicate results for pH and acid content which are comparable within formulation and experimental accuracy. The test for adhesion indicates better adhesion of the subject device. The device is intentionally more viscous than the predicate device to improve adhesion after placement. The test for water washability indicates marginally easier washability for the predicate device. This is a direct result of the intentionally increased viscosity (and adhesion) of the subject device. The washability of the subject device is satisfactory on consideration of the method of removal. ## CLINICAL DATA: There is none applicable ## CONCLUSIONS: The data summarised above indicates that the subject device is substantially equivalent to the predicate device. Any differences in performance are a result of improvements designed to render the product safer and more effective in clinical use.